Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2...
Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w...
Z-1570-2026March 25, 2026Waukesha, WI
Abbott Diagnostics Scarborough, Inc.
Class IIOngoing
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Compon...
Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Z-1565-2026March 25, 2026Scarborough, ME
Beckman Coulter Mishima K.K.
Class IIOngoing
DxC 700 AU, REF: B86444, B86446
Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Re...
Z-1552-2026March 18, 2026Sunto-Gun, N/A
Medartis AG
Class IIOngoing
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for ...
Reason: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Reason: A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Re...
Z-1553-2026March 18, 2026Sunto-Gun, N/A
Covidien LLC
Class IIOngoing
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 1...
Reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring s...
Z-1557-2026March 18, 2026Boulder, CO
Medartis AG
Class IIOngoing
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for ...
Reason: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Z-1550-2026March 18, 2026Basel Town, N/A
B Braun Medical Inc
Class IIOngoing
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and ...
Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Z-1481-2026March 11, 2026Bethlehem, PA
Roche Diagnostics Operations, Inc.
Class IIOngoing
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Produ...
Reason: Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended ...
Z-1476-2026March 11, 2026Indianapolis, IN
Datascope Corp.
Class IIOngoing
CS300 IABP. Software Version CS300 IABP C.01.
Reason: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Z-1487-2026March 11, 2026Mahwah, NJ
Datascope Corp.
Class IIOngoing
CS100 IABP. Software Version CS100 IABP Q.01.
Reason: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Z-1486-2026March 11, 2026Mahwah, NJ
B Braun Medical Inc
Class IIOngoing
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and inten...
Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Reason: There is the potential for the length of the trocar shaft to be too long.
Z-1485-2026March 11, 2026Center Valley, PA
B Braun Medical Inc
Class IIOngoing
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be us...
Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Reason: Software anomaly in the patient positioning system may result in positional discrepancy.
Z-1430-2026March 4, 2026Kashiwa, N/A
Baxter Healthcare Corporation
Class IIOngoing
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Reason: Pumps were released without full testing being performed, including occlusion alarm testing.
Z-1368-2026February 25, 2026Deerfield, IL
Olympus Corporation of the Americas
Class IOngoing
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatme...
Reason: Issue with software algorithm which may lead to overpressure events.
Z-1352-2026February 25, 2026Center Valley, PA
Olympus Corporation of the Americas
Class IOngoing
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treat...
Reason: Issue with software algorithm which may lead to overpressure events.
Z-1354-2026February 25, 2026Center Valley, PA
Intuitive Surgical, Inc.
Class IIOngoing
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Reason: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Z-1428-2026February 25, 2026Sunnyvale, CA
Olympus Corporation of the Americas
Class IOngoing
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and trea...
Reason: Issue with software algorithm which may lead to overpressure events.
Z-1353-2026February 25, 2026Center Valley, PA
Centinel Spine, Inc.
Class IIOngoing
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Reason: Products were mislabeled as the 6mm product but included the 5 mm product.
Reason: Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application w...
Z-1383-2026February 25, 2026Santa Clara, CA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Z-1345-2026February 18, 2026Best, N/A
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.