Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) ...
Reason: Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. When pr...
Z-0357-2019November 7, 2018Brea, CA
Beckman Coulter Inc.
Class IIITerminated
Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). Th...
Reason: Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for manual printing of barcodes. When pr...
Z-0356-2019November 7, 2018Brea, CA
Beckman Coulter Inc.
Class IIITerminated
Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to ...
Reason: Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the Sorting-Drive Client that is used for manual printing of barcodes; version ...
Z-0355-2019November 7, 2018Brea, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ra...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0305-2019November 7, 2018Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray ...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0308-2019November 7, 2018Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruct...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0306-2019November 7, 2018Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recons...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0303-2019November 7, 2018Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of ...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0310-2019November 7, 2018Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray...
Reason: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provid...
Z-0304-2019November 7, 2018Cleveland, OH
Data Innovations, LLC
Class IITerminated
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
Reason: Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument. This has been determined to be a driver malfunction. When an instrument t...
Z-0203-2019October 31, 2018South Burlington, VT
Philips Medical Systems Gmbh, DMC
Class IITerminated
Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
Reason: Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
Z-0239-2019October 31, 2018Hamburg, N/A
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0273-2019October 31, 2018Littleton, MA
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0272-2019October 31, 2018Littleton, MA
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoro...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0278-2019October 31, 2018Littleton, MA
Shimadzu Medical Systems Usa Com
Class IITerminated
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiogr...
Reason: Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into conta...
Z-0197-2019October 31, 2018Torrance, CA
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D f...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0276-2019October 31, 2018Littleton, MA
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic an...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0271-2019October 31, 2018Littleton, MA
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoro...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0274-2019October 31, 2018Littleton, MA
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0275-2019October 31, 2018Littleton, MA
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D flu...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0280-2019October 31, 2018Littleton, MA
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopi...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0277-2019October 31, 2018Littleton, MA
GE Medical Systems, LLC
Class IITerminated
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Reason: GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur...
Z-0201-2019October 31, 2018Waukesha, WI
Medtronic Navigation, Inc.-Littleton
Class IITerminated
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluorosc...
Reason: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and outpu...
Z-0279-2019October 31, 2018Littleton, MA
GE Medical Systems, LLC
Class IITerminated
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN,...
Reason: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or the...
Z-0110-2019October 24, 2018Waukesha, WI
GE Medical Systems, LLC
Class IITerminated
GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, ...
Reason: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or the...