STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunolo...
Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Z-2473-2025September 3, 2025Parsippany, NJ
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES /...
Reason: Antivirus software was not consistently installed on impacted devices during the implementation process.
Reason: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr...
Z-2421-2025September 3, 2025Waltham, MA
Drs Vascular, Inc
Class IIOngoing
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use...
Reason: Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not con...
Reason: When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a s...
Z-2297-2025August 20, 2025Maastricht, N/A
Thoratec LLC
Class IOngoing
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) ...
Reason: Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintend...
Z-2290-2025August 20, 2025Pleasanton, CA
Thoratec LLC
Class IOngoing
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equ...
Reason: Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintend...
Reason: Cannulated fenestrated polyaxial screws may be incorrectly labeled
Z-2280-2025August 20, 2025Plan-Les-Ouates, N/A
Philips Medical Systems (Cleveland) Inc
Class IIOngoing
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Reason: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Z-2239-2025August 13, 2025Gainesville, FL
Beckman Coulter, Inc.
Class IIOngoing
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Reason: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings ...
Z-2266-2025August 13, 2025Chaska, MN
Beckman Coulter, Inc.
Class IIOngoing
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Reason: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings ...
Z-2271-2025August 13, 2025Chaska, MN
Beckman Coulter, Inc.
Class IIOngoing
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Reason: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings ...
Z-2267-2025August 13, 2025Chaska, MN
Beckman Coulter, Inc.
Class IIOngoing
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Reason: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings ...
Z-2270-2025August 13, 2025Chaska, MN
Beckman Coulter, Inc.
Class IIOngoing
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Reason: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings ...
Z-2269-2025August 13, 2025Chaska, MN
Beckman Coulter, Inc.
Class IIOngoing
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Reason: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings ...
Z-2268-2025August 13, 2025Chaska, MN
CareFusion 303, Inc.
Class IOngoing
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occl...
Z-2179-2025August 13, 2025San Diego, CA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. ...
Reason: Potential for temporary loss of imaging (X-ray) functionality due to software issue.
Z-2189-2025August 6, 2025Best
Remote Diagnostic Technologies Ltd.
Class IIOngoing
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
Reason: Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an A...
Z-2175-2025August 6, 2025Farnborough
FUJIFILM Healthcare Americas Corporation
Class IIOngoing
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Reason: Devices had an unapproved slabbing software function enabled for use.
Reason: There is the potential that the silicone implant may contain foreign material
Z-2222-2025August 6, 2025Christchurch
Medtronic, Inc.
Class IIOngoing
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia app...
Reason: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a t...
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Z-2147-2025July 30, 2025Austin, TX
Medtronic, Inc.
Class IIOngoing
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia appli...
Reason: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a t...