Tag

defects
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...
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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...
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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...
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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...
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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...
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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)...
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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...
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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:...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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:...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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),...
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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...
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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...
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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...
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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...
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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...
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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...
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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:...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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.
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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...
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