Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the...
Z-0324-2026November 5, 2025Beachwood, OH
Beckman Coulter, Inc.
Class IIOngoing
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Reason: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/c...
Z-0412-2026November 5, 2025Miami, FL
Surgical Theater Inc
Class IIOngoing
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the...
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Z-0309-2026November 5, 2025Center Valley, PA
Surgical Theater Inc
Class IIOngoing
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the...
Z-0323-2026November 5, 2025Beachwood, OH
Surgical Theater Inc
Class IIOngoing
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the...
Z-0322-2026November 5, 2025Beachwood, OH
Surgical Theater Inc
Class IIOngoing
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the...
Z-0320-2026November 5, 2025Beachwood, OH
Alcon Research LLC
Class IIOngoing
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393...
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0306-2026November 5, 2025Fort Worth, TX
Aesculap Inc
Class IIOngoing
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Z-0310-2026November 5, 2025Center Valley, PA
Beckman Coulter, Inc.
Class IIOngoing
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Reason: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified m...
Z-0216-2026October 29, 2025Chaska, MN
Beckman Coulter, Inc.
Class IIOngoing
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
Reason: Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified m...
Z-0215-2026October 29, 2025Chaska, MN
Becton Dickinson & Co.
Class IIOngoing
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
Reason: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar...
Z-0240-2026October 29, 2025Sparks, MD
B BRAUN MEDICAL INC
Class IOngoing
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIA...
Reason: The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
Z-0070-2026October 29, 2025Allentown, PA
Wipro GE Healthcare Private Ltd.
Class IIOngoing
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube
Reason: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If th...
Z-0214-2026October 29, 2025Bengaluru
Wipro GE Healthcare Private Ltd.
Class IIOngoing
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
Reason: GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If th...
Z-0213-2026October 29, 2025Bengaluru
Tandem Diabetes Care, Inc.
Class IIOngoing
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Intero...
Reason: A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired w...
Z-0232-2026October 29, 2025San Diego, CA
Boston Scientific Corporation
Class IOngoing
Model Number U228, VISIONIST CRT-P EL MRI
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0105-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number U226, VISIONIST CRT-P EL
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0104-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L211 PROPONENT DR SL MRI Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0089-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L100, ESSENTIO SR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0092-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE SR SL (Model L300)
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLA...
Z-0079-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L101, ESSENTIO DR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCO...
Z-0093-2026October 22, 2025Saint Paul, MN
GE Medical Systems, LLC
Class IIOngoing
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica...
Z-0156-2026October 22, 2025Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Reason: The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica...