Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 21 of 120
Baxter Healthcare Corporation
Class II Ongoing
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Reason: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1416-2025 April 2, 2025 Deerfield, IL
Baxter Healthcare Corporation
Class II Ongoing
Baxter Stationary column TruSystem 7500, Product Code 1717020
Reason: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1410-2025 April 2, 2025 Deerfield, IL
Baxter Healthcare Corporation
Class II Ongoing
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Reason: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1413-2025 April 2, 2025 Deerfield, IL
Baxter Healthcare Corporation
Class II Ongoing
Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
Reason: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1417-2025 April 2, 2025 Deerfield, IL
Baxter Healthcare Corporation
Class II Ongoing
Baxter Floor mounting column TruSystem 7500, Product Code 1717021
Reason: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1411-2025 April 2, 2025 Deerfield, IL
Baxter Healthcare Corporation
Class II Ongoing
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
Reason: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1409-2025 April 2, 2025 Deerfield, IL
American Contract Systems, Inc.
Class II Ongoing
Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
Reason: Sterility assurance with procedure trays
Z-1425-2025 April 2, 2025 Chandler, AZ
Baxter Healthcare Corporation
Class II Ongoing
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Reason: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1418-2025 April 2, 2025 Deerfield, IL
American Contract Systems, Inc.
Class II Ongoing
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
Reason: Sterility assurance with procedure trays
Z-1426-2025 April 2, 2025 Chandler, AZ
FUJIFILM Healthcare Americas Corporation
Class II Ongoing
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Reason: The incorrect computed patient age is showing in VX for patients less than 3 months old.
Z-1407-2025 March 26, 2025 Lexington, MA
Merge Healthcare, Inc.
Class II Ongoing
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integra...
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clini...
Z-1402-2025 March 26, 2025 Hartland, WI
Brainlab AG
Class II Ongoing
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Reason: Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Z-1392-2025 March 26, 2025 Munich, N/A
Merge Healthcare, Inc.
Class II Ongoing
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and commun...
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clini...
Z-1401-2025 March 26, 2025 Hartland, WI
CareFusion 303, Inc.
Class II Ongoing
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired...
Reason: Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive tim...
Z-1375-2025 March 26, 2025 San Diego, CA
Merge Healthcare, Inc.
Class II Ongoing
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a pictur...
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clini...
Z-1400-2025 March 26, 2025 Hartland, WI
Merge Healthcare, Inc.
Class II Ongoing
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communica...
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clini...
Z-1398-2025 March 26, 2025 Hartland, WI
Merge Healthcare, Inc.
Class II Ongoing
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified a...
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clini...
Z-1399-2025 March 26, 2025 Hartland, WI
ZOLL Medical Corporation
Class II Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (A...
Reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1317-2025 March 19, 2025 Chelmsford, MA
ZOLL Medical Corporation
Class II Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-8...
Reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1319-2025 March 19, 2025 Chelmsford, MA
ZOLL Medical Corporation
Class II Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated ext...
Reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1320-2025 March 19, 2025 Chelmsford, MA
ZOLL Medical Corporation
Class II Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for t...
Reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1323-2025 March 19, 2025 Chelmsford, MA
ZOLL Medical Corporation
Class II Ongoing
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (1...
Reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Z-1322-2025 March 19, 2025 Chelmsford, MA
Spectrum Medical Inc
Class II Ongoing
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version:...
Reason: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Z-1327-2025 March 19, 2025 Fort Mill, SC
CareFusion 303, Inc.
Class I Ongoing
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Reason: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Z-1305-2025 March 19, 2025 San Diego, CA
CareFusion 303, Inc.
Class I Ongoing
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Reason: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Z-1304-2025 March 19, 2025 San Diego, CA