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 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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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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