LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Reason: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate meth...
Z-0965-2026December 31, 2025Lake Forest, IL
Zimmer, Inc.
Class IIOngoing
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m...
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ...
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0952-2026December 24, 2025Tyne & Wear
Abbott Laboratories
Class IIOngoing
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Reason: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance i...
Z-0961-2026December 24, 2025Irving, TX
Mindray DS USA, Inc. dba Mindray North America
Class IIOngoing
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: ...
Reason: When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Z-0920-2026December 24, 2025Mahwah, NJ
GE Healthcare GmbH
Class IIOngoing
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Reason: GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history informati...
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0951-2026December 24, 2025Tyne & Wear
DICOM Grid, Inc.
Class IIOngoing
Intelerad InteleShare software, with ProViewer component
Reason: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare...
Z-0941-2026December 24, 2025Raleigh, NC
Fresenius Kabi USA, LLC
Class IOngoing
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reason: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Z-0885-2026December 24, 2025North Andover, MA
Fresenius Medical Care Holdings, Inc.
Class IIOngoing
5008X CAREsystem +CLiC +CDX;
Reason: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Reason: When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to...
Reason: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0955-2026December 24, 2025Tyne & Wear
Philips North America Llc
Class IIOngoing
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Reason: If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components locat...
Z-0882-2026December 10, 2025Cambridge, MA
Philips North America Llc
Class IIOngoing
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Reason: If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components locat...
Z-0881-2026December 10, 2025Cambridge, MA
INTELERAD MEDICAL SYSTEMS INCORPORATED
Class IIOngoing
IntelePACS - InteleConnect / TechPortal
Reason: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant ...
Z-0723-2026December 3, 2025Montreal, N/A
Medtronic MiniMed, Inc.
Class IIOngoing
CareLink Clinic, REF: MMT-7350
Reason: Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed ...
Z-0594-2026December 3, 2025Northridge, CA
DERMASENSOR INC
Class IIOngoing
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Reason: Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Z-0505-2026November 26, 2025Pleasanton, CA
Beckman Coulter Inc.
Class IIOngoing
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent d...
Reason: Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Z-0508-2026November 26, 2025Pleasanton, CA
Exactech, Inc.
Class IIOngoing
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a com...
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-0537-2026November 26, 2025Gainesville, FL
Exactech, Inc.
Class IIOngoing
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm 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.