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defects
The 2015 Amendment 1 update to IEC 62304 added a new clause that requires identification of “categories of defects associated with the selected programming technology” and providing analysis and other evidence demonstrating “that these defects do not contribute to unacceptable risk.”  Read a recent article on challenges with using C language.
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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...
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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...
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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 /...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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....
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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...
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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...
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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....
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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....
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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)...
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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...
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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”...
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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...
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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...
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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...
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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...
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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.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
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Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

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Dates:  June 4-6, 2020

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