MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1...
Reason: When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
Z-0503-2026November 26, 2025Stockholm
Sterilmed, Inc.
Class IIOngoing
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/...
Reason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such a...
Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Z-0507-2026November 26, 2025Pleasanton, CA
Sterilmed, Inc.
Class IIOngoing
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Nu...
Reason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such a...
Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Z-0506-2026November 26, 2025Pleasanton, CA
Exactech, Inc.
Class IIOngoing
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Z-0535-2026November 26, 2025Gainesville, FL
Sonesta Medical AB
Class IIOngoing
Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the u...
Reason: Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Z-0460-2026November 19, 2025Solna
Abbott Laboratories
Class IIOngoing
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq A...
Reason: Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Z-0489-2026November 19, 2025Santa Clara, CA
Tandem Diabetes Care, Inc.
Class IOngoing
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism...
Reason: Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue ...
Z-0427-2026November 12, 2025San Diego, CA
Elekta, Inc.
Class IIOngoing
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System i...
Reason: Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
Z-0433-2026November 12, 2025Atlanta, GA
Spacelabs Healthcare, Ltd.
Class IIOngoing
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentine...
Reason: Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhyth...
Z-0416-2026November 12, 2025Hertford, N/A
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' 8065000356...
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axi...
Z-0376-2026November 5, 2025Cambridge, MA
Surgical Theater Inc
Class IIOngoing
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
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-0325-2026November 5, 2025Beachwood, OH
Aesculap Inc
Class IIOngoing
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT 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-0311-2026November 5, 2025Center Valley, PA
Medistim Asa
Class IIOngoing
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound ...
Reason: Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer S...
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axi...
Z-0375-2026November 5, 2025Cambridge, MA
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' 8065750918...
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0305-2026November 5, 2025Fort Worth, TX
PHILIPS MEDICAL SYSTEMS
Class IIOngoing
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Reason: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axi...
Z-0377-2026November 5, 2025Cambridge, MA
Surgical Theater Inc
Class IIOngoing
Surgical Navigation Advanced Platform Patient Engagement (PE 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-0321-2026November 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' 8065000250...
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0304-2026November 5, 2025Fort Worth, TX
Dexcom, Inc.
Class IOngoing
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description:...
Reason: A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms,...
Z-0318-2026November 5, 2025San Diego, CA
Vantive US Healthcare LLC
Class IIOngoing
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Reason: Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the a...
Z-0409-2026November 5, 2025Deerfield, IL
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' 8065000252...
Reason: Due to incomplete seals in the pouch which provide the sterile barrier.