Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions);...
Reason: a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting ...
Z-2039-2025July 9, 2025Rochester, NY
CHANGE HEALTHCARE CANADA COMPANY
Class IIOngoing
Change Healthcare Cardiology Hemo Software
Reason: Due to complaints, software update may cause software to unexpectedly shutdown.
Z-2071-2025July 9, 2025Richmond
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Produc...
Reason: a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting ...
Z-2040-2025July 9, 2025Rochester, NY
Siemens Medical Solutions USA, Inc
Class IIOngoing
interventional fluoroscopic x-ray system
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorr...
Reason: A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting ...
Z-2038-2025July 9, 2025Rochester, NY
Siemens Medical Solutions USA, Inc
Class IIOngoing
interventional fluoroscopic x-ray system
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorr...
Z-2020-2025July 9, 2025Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
interventional fluoroscopic x-ray system
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorr...
Z-2021-2025July 9, 2025Malvern, PA
BIGFOOT BIOMEDICAL
Class IIOngoing
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Conf...
Reason: Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose...
Z-1997-2025July 2, 2025Milpitas, CA
Encore Medical, LP
Class IIOngoing
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devi...
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Z-2008-2025July 2, 2025Austin, TX
Encore Medical, LP
Class IIOngoing
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devi...
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Z-2009-2025July 2, 2025Austin, TX
Insulet Corporation
Class IIOngoing
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to downl...
Reason: Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal sep...
Z-2016-2025July 2, 2025Acton, MA
Encore Medical, LP
Class IIOngoing
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devi...
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Reason: Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or...
Z-2028-2025July 2, 2025Brea, CA
Philips North America Llc
Class IIOngoing
Spectral CT. Computed tomography X-ray system.
Reason: Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional ...
Z-2034-2025July 2, 2025Cambridge, MA
Encore Medical, LP
Class IIOngoing
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devi...
Reason: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Z-2011-2025July 2, 2025Austin, TX
CareFusion 303, Inc.
Class IIOngoing
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352]...
Reason: During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an err...
Z-2017-2025July 2, 2025San Diego, CA
ICU Medical, Inc.
Class IIOngoing
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Reason: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in ...
Z-1990-2025June 25, 2025Lake Forest, IL
ICU Medical, Inc.
Class IIOngoing
ICU Medical Plum Solos, Item number 400011001; infusion pump
Reason: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in ...
Reason: Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Z-1978-2025June 25, 2025Guangzhou, N/A
Tecfen Medical
Class IIOngoing
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) ...
Reason: Sterility assurance for Ophthalmic knives.
Z-1954-2025June 18, 2025Santa Barbara, CA
Tecfen Medical
Class IIOngoing
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to b...
Reason: Sterility assurance for Ophthalmic knives.
Z-1952-2025June 18, 2025Santa Barbara, CA
Cardinal Health 200, LLC
Class IICompleted
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Reason: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Z-1918-2025June 18, 2025Waukegan, IL
Cardinal Health 200, LLC
Class IICompleted
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Reason: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.