Tag

defects
On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software.  The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies.  This standard is lengthy and technical in terms of its approach to defect...
Read More
Glanced through the latest FDA warning letters today.  From the FDA Medical Device & Radiological Health Operations West/Division 3 I see the inspector pointing out “This design validation also fails to include software validation [emphasis mine] to assure software will perform as intended and will not prevent safe operation by the user.”   Of course this is...
Read More
Company: Synaptive Medical Inc. Date of Enforcement Report: 11/26/2018 Class II: PRODUCT BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only /...
Read More
Company: Synaptive Medical, Inc. Date of Enforcement Report: 10/9/2018 Class l: PRODUCT: Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration provides detailed three-dimensional (3D) images of a patient’s brain to help surgeons safely navigate surgical tools used during brain surgery. Recall Number: Z-0470-2019 REASON: Synaptive Medical has initiated this recall due to a software defect found in the BrightMatter...
Read More
Company:Invivo Corporation.Date of Enforcement Report 4/11/2018 Class lI: PRODUCT DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed...
Read More
Company:Philips Electronics North America Corporation Date of Enforcement Report 3/14/2018 Class lI: PRODUCT Philips Network Firewall (Cisco ASA 5506)Product Usage:The Cisco ASA 5506-X provides IPv4 and IPv6 Routing and Network Address Translation (NAT) capabilities. It also provides the following: Port Filtering Stateful Packet Inspection Default Protection Policies These default policies trust all outgoing traffic and...
Read More
Company:Edwards Lifesciences, LLCDate of Enforcement Report 27/2018 Class lI: PRODUCT Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards...
Read More
Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a...
Read More
Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into...
Read More
Company:Beckman Coulter Inc.. Date of Enforcement Report 8/2/2017 Class lII: PRODUCT Beckman Coulter PK7300(R) Automated Microplate System, Catalogue Numbers: N3209000 and N2007600y Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number B-0741-2017 REASON Beckman Coulter’s PK7300, associated with a defect or glitch with the dispensing monitoring board, was distributed.. RECALLING FIRM/MANUFACTURER Bedkman Coulter, Brea, CA...
Read More
AAMI Software and IT-related standards working groups include one for interoperability (with 3 standards work items), one for Device Security (with 2 standards work items), one for Wireless, one for SW Defect Classification, and one for AAMI/UL 2800-1 for specification of architecture independent requirements. There is also a separate Health IT Committee with several items...
Read More
Company: Nexstim PLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. Recall Number Z-2319-2017 REASON Software defect: the NBS software may...
Read More
Company: Nexstim PLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of...
Read More
Company: Mobius Medical Systems, LP Date of Enforcement Report 5/24/2017 Class lI: PRODUCT Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially...
Read More
Company:Philips VisicuDate of Enforcement Report 4/12/2017 Class lI: PRODUCT eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient...
Read More
Company: Blood Bank Computer Systems, IncDate of Enforcement Report 1/25/2017 Class lI: PRODUCT Blood Bank Control System (BBCS) Primary Application, V 5.4.3, 5.5 is intended to address all phases of donor and transfusion services. The software is also capable of operating with or without ABO QuickPass (BK14130) to allow donors to complete Computer Assisted Self...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be...
Read More
Company: Mevion Medical Systems, Inc. Date of Enforcement Report 11/23/2016 Class lI: PRODUCT MEVION S250 Product Usage: Proton Radiation Therapy System Recall Number Z-0411-2017 REASON Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with...
Read More
Company: Thermo Finnigan LLC. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Endura MR Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and...
Read More
Company: Bio-Rad Laboratories, Inc. Date of Enforcement Report 9/7/2016 Class lII: PRODUCT TANGO Infinity, catalog # 850000010, Software version 1.2 Recall Number B-0746-16 REASON TANGO Infinity System, with a defect or glitch allowing an incorrect microplate type, was distributed. RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories, Inc. , Redmond, WA on 9/1/2016. Voluntary: Firm Initiated recall is ongoing....
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance CT 16 Power Computed Tomography X-ray systems X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2370-2016 REASON Software defect causing intermittently slow response...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Stratus CS STAT Fluorometric Analyzer-microproc essor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531 Recall Number Z-2525-2016 REASON Software defect, where either an Above...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray systems X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2371-2016 REASON Software defect causing intermittently slow response of Host....
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance 16 Computed Tomography X-ray systems X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2369-2016 REASON Software defect causing intermittently slow response of Host....
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance BigBore Oncology Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2367-2016 REASON Software defect causing intermittently slow response of Host. RECALLING...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2366-2016 REASON Software defect causing intermittently slow response of Host. RECALLING FIRM/MANUFACTURER...
Read More
Company: Ge Healthcare ItDate of Enforcement Report 8/3/2016 Class lI: PRODUCT Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing...
Read More
Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Recall Number Z-1716-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
Read More
Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Recall Number Z-1718-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
Read More
Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Recall Number Z-1717-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
Read More
Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Recall Number Z-1719-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
Read More
Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Recall Number Z-171Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3)...
Read More
Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Recall Number Z-1713-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
Read More
Company: Sedecal USA, Inc.Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Sedecal SA Mobile Diagnost w DR x-ray system. Recall Number Z-1691-2016 REASON Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type ” Newborn”...
Read More
Company: Philips Healthcare Date of Enforcement Report 6/15/2016 Class lI: PRODUCT Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Recall Number Z-1714-2016 REASON Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...
Read More
Company: Siemens Healthcare Diagnostics Inc. Date of Enforcement Report 6/1/2016 Class lI: PRODUCT Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such...
Read More
Company: Siemens Healthcare Diagnostics Inc. Date of Enforcement Report 6/1/2016 Class lI: PRODUCT Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such...
Read More
Company: Neusoft Medical Systems Co., Ltd. Date of Enforcement Report 5/18/2016 Class lI: PRODUCT NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) Recall Number Z-1650-2016 REASON It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of...
Read More
The link provided is our revised checklist for changes in Amendment 1. You will need to login as a paid subscriber to download this checklist.
Read More
Amendment 1 of” “IEC 62304 Medical device software — Software Life cycle processes” was issued in 2015. Although the focus of the Amendment was to include a special provision for Legacy software as well as clarifications and changes to Safety Classification, a number of other substantive changes were made.including significant additional requirements for Class A...
Read More
In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for Legacy software and clarifications to the use of risk in safety classification keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: 1. Reduction in the...
Read More
In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for legacy software and clarifications to the use of risk in safety classification, keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: Reduction in the exemptions...
Read More
Company:.Visicu, Inc.Date of Enforcement Report 12/16/2015 Class lI: PRODUCT The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an...
Read More
Company:Carestream Health Inc.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. Recall Number Z-2449-2015 REASON Carestream became aware of an issue with...
Read More
Company: Philips Electronics North America Corporation Date of Enforcement Report 9/2/2015 Class lI: PRODUCT Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians. Recall Number Z-2383-2015 REASON The system is designed to emit a...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2194-2015 REASON Philips has identified four...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2195-2015 REASON Philips has...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2196-2015 REASON Philips has...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2198-2015 REASON Philips has identified...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2199-2015 REASON Philips has...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2197-2015 REASON Philips has identified...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2193-2015 REASON Philips has...
Read More
Soft Computer Consultants, Inc.Product: Class I/II software systems Date: 4/30/2015 1. Failure to adequately establish procedures for CAPA as required by 21 CFR 820.100(a). Specifically, A. Product Change Controls (PCCs) which are corrective and preventive actions for handling software coding defects do not always include investigating the cause of all nonconformities relating to product, processes...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/8/2015 Class lI: PRODUCT Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH Recall Number Z-1359-2015 REASON Philips discovered that a software defect exists in marketed product wherein the...
Read More
Company: Carl Zeiss Meditec AG Date of Enforcement Report 2/11/2015 Class lI: PRODUCT FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/24/2014 Class lI: PRODUCT Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d)...
Read More
Company: Mevion Medical Systems, Inc.. Date of Enforcement Report 12/17/2014 Class lI: PRODUCT MEVION S250, used for proton radiation therapy. Recall Number Z-0588-2015 REASON Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/3/2014 Class lI: PRODUCT IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 Recall Number Z-0473-2015 REASON Software defect RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH 11/9/2014. Voluntary:...
Read More
Company: BRainlab AG.Date of Enforcement Report:6/11/2014 Class lI: PRODUCT Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or...
Read More
Company: NAGFA Corp.Date of Enforcement Report:6/4/2014 Class lI: PRODUCT IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography. Recall Number Z-1662-2014 REASON Failure to effectively install and test a hotfix to correct the...
Read More
Company: GE Healthcare Date of Enforcement Report:5/14/2014 Class lI: PRODUCT Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with...
Read More
The Wall Street Journal reports that “the top federal auto-safety regulator will defend his agency before Congress on Tuesday, telling lawmakers that General Motors had “critical information” that would have helped it identify a defect earlier in the Chevrolet Cobalt and other vehicles and might have changed the agency?s course in investigating the problems.In prepared...
Read More
A January 2014 ACM Journal has an interesting article on software verification at NASA JPL for the Mars Curiosity Rover at the link provided. A few things that I found interesting: Their standard for flight software is ISO-C99. The coding standard at JPL (http://lars-lab.jpl.nasa.gov/JPL_Coding_Standard_C.pdf) is risk-based and has 6 “levels of compliance”. LOC-5 and LOC-6...
Read More
The link provided is to an article on Fuzz testing. This type of testing involves injecting bad data to challenge your applications and safeguards. This type of testing can be important to verify risk control measures and data integrity checks are verified. The name Fuzz testing is a fairly recent moniker for techniques that have...
Read More
Test driven development (TDD) is the creation and execution of automated tests early in development which fail, by design, until a programmed element is implemented. There are many terms to describe the process, but few will refute its value. Re-discovered in 2003, manufacturers are taking hold of this methodology, ensuring new hires can successfully and...
Read More
Company: SCC Soft Computer Date of Enforcement Report:12/18/2013 Class lI: PRODUCT SoftBank II versions: 23.1, 23.2, 25.0, 25.1, 25.2, and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x Recall Number B-0216-14 REASON Blood Bank software with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwataer, FL on 11/11//2013. Voluntary: Firm Initiated...
Read More
Company: Haemonetics Software Solutions Date of Enforcement Report:12/11/2013 Class lI: PRODUCT ElDorado Donor Doc Software, comprehensive donor health qualification computer system, run in a native Internet Explorer browser that is displayed in kiosk mode. Versions 2.5.0, 2.5.0 (SR1), 2.6.0, 2.6 (SR1), 2.7.0 Recall Number B-0008-14 REASON Blood Bank Software, with a defect or glitch, was...
Read More
Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT Ortho Verseia Pipetter (VERSEIA) Recall Number B-2518-13 REASON ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results. RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics Inc, Raritan, NJ on 8/21/2013. Voluntary:...
Read More
Company: One Lambda Inc. Date of Enforcement Report: 11/6/2013 Class lI: PRODUCT HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR Recall Number B-2326-13 REASON HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed. RECALLING FIRM/MANUFACTURER One Lambda Inc., Canoga Park, CA...
Read More
Company: Data Innovations. Date of Enforcement Report: 9/11/2013 Class ll: PRODUCT 1. Data Innovations Instrument Manager Software Any version of Instrument Manager using the Roche Cobas e411 (rche411) driver versions 8.00.0001 or v8.00.002 Recall Number B-2265-13 2. Data Innovations Instrument Manager software Model – Versions 8.12.01 Recall Number B-2299-13 REASON Laboratory software, with a defect...
Read More
Company: Del Mar Reynolds Medical, Ltd. Date of Enforcement Report: 7/31/2013 Class lI: PRODUCT Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used...
Read More
Company:Blood Bank Computer Systems, Inc. Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT Blood Bank software Primary Application with Model numbers 5.4.0.2 and 5.4.1. Recall Number B-2148-13 REASON Blood Bank software Primary Application (Model Numbers 5.4.0.2 and 5.4.1), with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc., Auburn, WA on...
Read More
Company:Blood Bank Computer Systems, Inc .Date of Enforcement Report 4/17/2013 Class ll: PRODUCT Blood bank software Primary Application with Model numbers 5.4.0; 5.4.0.1; 5.4.0.2; and 5.4.1 Recall Number B-1345-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc, Auburn, WA, on 12/5/2012. Voluntary: Firm Initiated recall...
Read More
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/10/2013 Class ll: PRODUCT SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS...
Read More
Company:Intel-GE Care Innovations LLC. Date of Enforcement Report 3/6/2013 Class ll: PRODUCT QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents’ movements. Recall Number Z-0877-2013 REASON Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect...
Read More
Company:Blood Bank Computer Systems, Inc Date of Enforcement Report 2/13/2013 Class ll: PRODUCT Blood Bank Control System (BBCS) Primary Application 5.0 – software for device. Recall Number B-0726-13 REASON Blood Bank software, with a defect or glitch, was distributed.. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc Auburn, WA on 10/18/2011. Voluntary: Firm Initiated recall is...
Read More
Company:Dept Of Veterans Affairs Office Of Information & Technology Date of Enforcement Report 2/13/2013 Class ll: PRODUCT VistA Blood Establishment Computer Software (VBECS) Recall Number B-0673-13 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Dept Of Veterans Affairs Office Of Information & Technology, Hines, IL on 11/2/2012. Voluntary: Firm Initiated recall is...
Read More
Company:Becton Dickinson & Co. Date of Enforcement Report 1/30/2013 Class ll: PRODUCT BD MAX ™ (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** The BD MAX” System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification...
Read More
Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataCare GM DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data. Recall Number Z-0492-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and...
Read More
Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data. Recall Number Z-0493-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older),...
Read More
Company: Roche Molecular Systems Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. Recall Number Z-0491-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which...
Read More
Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche Applied Science MagNA Pure LC Version 3.0. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials. Recall Number Z-0485-2013...
Read More
Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche LightCycler 2.0 Instrument with software version 4.1. LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve...
Read More
Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche MagNA Pure 96 System Version 1.0 (Software Version 2.0) for in vitro diagnostic use. The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This...
Read More
Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche Molecular Biochemicals LightCycler 1.2 with software version 3.5. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve...
Read More
Company:Medical Information Technology, Inc Date of Enforcement Report 11/21/12 Class ll: PRODUCT MEDITECH Blood Bank Software, Client Server Releases 5.6, 5.65, 6.0,6.05, 6.06, and 6.13. Recall Number B-0102-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood, MA on 8/20/12 Voluntary: Firm Initiated recall is ongoing...
Read More
Company:Medical Information Technology, Inc Date of Enforcement Report 11/21/12 Class ll: PRODUCT MEDITECH Blood Bank Software – Client Server Releases 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1 and 6.12. Recall Number B-0101-13 REASON Blood Bank Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Medical Information Technology, Inc., Westwood, MA on 7/24/12 Voluntary:...
Read More
Company:Sunquest Information Systems, Inc. Date of Enforcement Report 10/17/12 Class ll: PRODUCT Sunquest Laboratory. Sunquest Application Interfacing Outbound Department of Health Interface. Recall Number B-2584-12 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tuscon, AZ on 12/14/2009. Voluntary: Firm Initiated recall was terminated. VOLUME OF PRODUCT IN COMMERCE...
Read More
Company:SCC Soft Computer Date of Enforcement Report 9/26/12 Class ll: PRODUCT Product is SoftBank software (versions 21.4.2 to 23.0.0). Recall Number B-2337-12 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Palm Harbor, FL on 2/23/2006. Voluntary: Firm Initiated recall has been terminated. VOLUME OF PRODUCT IN COMMERCE 10 units...
Read More
Company:Micro Typing Systems Inc. Date of Enforcement Report 9/19/12 Class ll: PRODUCT ORTHO-ProVue (TM) A modular, microprocessor-controled instrument.B-2373-12 REASON ORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed. RECALLING FIRM/MANUFACTURER Capintec Inc., Pompano Beach FL on 7/8/2004. Voluntary: Firm Initiated recall has been terminated. VOLUME OF PRODUCT IN...
Read More
Company:Philips Healthcare Date of Enforcement Report 7/23/12 Philips Healthcare Recalls Faulty Patient Data Exchange System Philips Healthcare is recalling a faulty patient data exchange system after finding that the tool sometimes sent incomplete cardiology reports to patients’ electronic health records, the Wall Street Journal’s “CIO Journal” reports. About the Problem The issue occurred when clinicians...
Read More
Company:Safe Trace Tx (Horizon Blood Bank, Haemonetics Software SolutionsDate of Enforcement Report 5/30/12 Class ll: PRODUCT SafeTrace Tx, also rebranded as Horizon Blood Bank Haemonetics Software Solutions (formerly Wyndgate Technologies) Recall # B-1434-12 REASON Safe Trace Tx (Horizon Blood Bank, Haemonetics Software Solutions), with a software glitch or defect that could result in an ABO...
Read More
Company:Viterion HealthcareDate of Enforcement Report 5/2/12 Class ll: PRODUCT Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Common Name: Viterion100 TeleHealth Monitor — Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The...
Read More
Company:Ortho-Clinical Diagnostics Date of Enforcement Report 5/2/12 Class ll: PRODUCT 1) VITROS? ECi Immunodiagnostic System, Catalog No. 8633893 — COMMON/USUAL NAME: VITROS? ECi System. All systems that has Software Version 3.8 or below installed and on which the VITROS? Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic...
Read More
Company:Philips Medical Systems (Cleveland) Inc. Date of Enforcement Report 12/27/11 Class ll: PRODUCT 1) Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine...
Read More
Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 12/15/11 Class ll: PRODUCT 1) Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical...
Read More
The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304.
Read More
Company:Alaris Products, FDA News FOR IMMEDIATE RELEASE P06-119 August 28, 2006 Media Inquiries: Catherine McDermott, 301-827-6242 Consumer Inquiries: 888-INFO-FDA United States Marshals Seize Defective Infusion Pumps Made by Alaris Products Pumps Can Deliver Excess Medication and Harm Patients At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the...
Read More
1 2

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.