Tag

softwarechange
Company: Devicor Medical Products Inc Date of Enforcement Report: 10/14/2020 Class III PRODUCT Neoprobe GDS Control Unit, Model Number NPCU3 Recall Number: Z-0070-2021 REASON It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011...
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Company: Medtronic Inc. Date of Enforcement Report: 9/23/2020 Class II PRODUCT The Guardian Connect App CSS7200 iOS – Product Usage: intended for use by patients with a compatible consumer mobile device. Recall Number: Z-2980-2020 REASON As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous...
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Company: Varian Medical Systems, Inc. Date of Enforcement Report: 5/13/2020 Class II PRODUCT Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 – Product Usage: is intended to assist the clinician in the delivery of external beam...
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Company: GE Healthcare, LLC Date of Enforcement Report: 6/10/2020 Class II PRODUCT System, Tomography Computed Emmission Recall Number: Z-2258-2020 REASON GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic...
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Company: Boston Scientific Corporation Date of Enforcement Report: 5/7/2020 Class II PRODUCT iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System Recall Number: Z-1804-2020 REASON Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will...
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Company: Sysmex America, Inc. Date of Enforcement Report: 4/22/2020 Class II PRODUCT The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 4/15/2020 Class II PRODUCT LabPro Data Management System, UDI: 15099590676872 – Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually...
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Company: Boston Scientific Corporation Date of Enforcement Report: 3/25/2020 Class II PRODUCT Boston Scientific, LATITUDE Programming System, Model 3300 – Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator...
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Company: St Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report:3/3/2020 Class II PRODUCT Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330 Recall Number: Z-1351-2020 REASON Past updates to programmers and transmitters may lead some implantable...
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Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT ORTHO VISION Analyzer for ID-MTS Gel Cards (ORTHO VISION), Software Version 5.12.3 and 5.12.4, Product Code: 6904577 Recall Number: B-0800-2019 ORTHO VISION Max Analyzer for ID-MTS Gel Cards (ORTHO VISION Max), Software Version 5.12.3 and 5.12.4, Product Code: 6904576 B-0801-2019 REASON Ortho...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 7/24/2019 Class II PRODUCT Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network...
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Company: Hamilton Medical Date of Enforcement Report: 7/12/2019 Class I PRODUCT Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001) Recall Number: Z-1874-2019 REASON New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted....
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Company: Abbott Laboratories Inc. (St Jude Medical) Date of Enforcement Report: 6/5/2019 Class II PRODUCT TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) Recall Number: Z-1493-2019 REASON In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the...
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Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 5/22/2019 Class II: PRODUCT Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN...
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Company: Advanced Bionics, LLC Date of Enforcement Report: 4/10/2019 Class II: PRODUCT Naida CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150. Recall Number: Z-1083-2019 Naida CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150. Recall Number: Z-1084-2019 Naida...
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Company: NEUSOFT MEDICAL SYSTEMS IMP & EX Date of Enforcement Report: 2/5/2019 Class II: PRODUCT NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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...
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Company: Becton, Dickinson and Company, BD Biosciences Date of Enforcement Report: 2/1/2019 Class III: PRODUCT BD FACSLyric(TM) 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric(TM) is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell...
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FDA posted a Medtronic announcement today that the company is launching a voluntary field action (VFA) for a software update on Puritan Bennett 980 Ventilators. The voluntary field corrective action is a software update to address customer feedback. The software updates the external USB Drive performance and its impact on Graphical User Interface (GUI) functionality...
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Company: Johnson & Johnson Surgical Vision Inc Date of Enforcement Report 10/10/2018 Class II: PRODUCT OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Recall Number: Z-0066-2019 REASON Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on...
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The FDA issued a final guidance entitled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device)” dated October 25, 2017. This guidance clarifies for the industry how to determine which software changes to a 510(k)-cleared device require a new 510(k). It seems to reflect what the FDA has applied in...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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