BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Reason: Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in del...
Z-1223-2024March 13, 2024San Diego, CA
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is...
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is...
Z-1233-2024March 13, 2024Rochester, NY
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is...
Z-1230-2024March 13, 2024Rochester, NY
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is...
Z-1229-2024March 13, 2024Rochester, NY
Zyno Medical LLC
Class IIOngoing
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or o...
Reason: When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a ...
Z-1183-2024March 6, 2024Natick, MA
Baxter Healthcare Corporation
Class IOngoing
Baxter Exactamix Pro 2400, REF EXM24DY
Reason: An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in ...
Z-1002-2024February 28, 2024Deerfield, IL
PTW-FREIBURG
Class IIOngoing
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
Reason: Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individua...
Z-1181-2024February 28, 2024Freiburg Im Breisgau, N/A
Canon Medical System, USA, INC.
Class IIOngoing
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, be...
Reason: VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, suc...
Z-1154-2024February 28, 2024Tustin, CA
Abiomed, Inc.
Class IITerminated
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Reason: Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not r...
Z-1175-2024February 28, 2024Danvers, MA
Baxter Healthcare Corporation
Class IOngoing
Baxter Exactamix Pro 1200, REF EXM12DY
Reason: An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in ...
Z-1001-2024February 28, 2024Deerfield, IL
Thoratec Corp.
Class IOngoing
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application...
Reason: Due to software and controller systems that results in unexpected pump start or pump stop.
Z-0842-2024February 14, 2024Pleasanton, CA
PHILIPS MEDICAL SYSTEMS
Class IIOngoing
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
Reason: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Z-1055-2024February 14, 2024Cambridge, MA
PHILIPS MEDICAL SYSTEMS
Class IIOngoing
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Reason: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Z-1054-2024February 14, 2024Cambridge, MA
Beckman Coulter, Inc.
Class IIOngoing
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
Reason: There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies ...
Z-0982-2024February 14, 2024Chaska, MN
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Reason: Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or tabl...
Z-0861-2024February 7, 2024Best
Smiths Medical ASD Inc.
Class IOngoing
smiths medical Medfusion Model 3500 Syringe pump
Reason: Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with In...
Z-0863-2024February 7, 2024Minneapolis, MN
Smiths Medical ASD Inc.
Class IOngoing
smiths medical Medfusion Model 4000 syringe pump
Reason: Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, ...
Z-0864-2024February 7, 2024Minneapolis, MN
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Reason: Loss of connectivity between the FlexArm and the Table due to a software issue.
Z-0860-2024February 7, 2024Best
Philips North America Llc
Class IIOngoing
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Reason: Multiple software issues that affect device functionality.
Z-0725-2024January 24, 2024Cambridge, MA
Philips Healthcare (Suzhou) Co., Ltd.
Class IIOngoing
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Reason: Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These inclu...
Z-0640-2024January 17, 2024Suzhou
Boston Scientific Corporation
Class IIOngoing
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ...
Reason: The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
Z-0673-2024January 17, 2024Saint Paul, MN
Insulet Corporation
Class IOngoing
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App ...
Reason: The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the...
Z-0591-2024January 10, 2024Acton, MA
Abiomed, Inc.
Class IIOngoing
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Reason: The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email featur...
Z-0636-2024January 10, 2024Danvers, MA
Covidien
Class IIOngoing
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Reason: Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable