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-0102-2026October 22, 2025Saint Paul, MN
Canon Medical System, USA, INC.
Class IIOngoing
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures f...
Reason: It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed...
Z-0037-2026October 15, 2025Tustin, CA
CHANGE HEALTHCARE CANADA COMPANY
Class IIOngoing
Change Healthcare Radiology Solutions software version 14.2.2
Reason: Due to software issue, radiology reports may not be fully displayed when viewing.
Z-0030-2026October 8, 2025Richmond, N/A
Bard Peripheral Vascular Inc
Class IIOngoing
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop...
Reason: Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Abla...
Z-2638-2025October 8, 2025Tempe, AZ
Zap Surgical Systems
Class IIOngoing
ZAP-X Radiosurgery System, Model: 300150
Reason: If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automat...
Z-2639-2025October 8, 2025San Carlos, CA
bioMerieux, Inc.
Class IIOngoing
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identifi...
Reason: Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Z-2671-2025October 8, 2025Durham, NC
MedicalCommunications GmbH
Class IIOngoing
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System...
Reason: Potential that the measured value may be smaller than the actual area.
Z-2673-2025October 8, 2025Heidelberg, N/A
Draeger, Inc.
Class IOngoing
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetiz...
Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Z-2616-2025October 8, 2025Telford, PA
Draeger, Inc.
Class IOngoing
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthet...
Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Reason: Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet Firs...
Reason: Measles IgM Test Kit lacks premarket approval or clearance.
Z-2552-2025September 17, 2025Doral, FL
Encore Medical, LP
Class IIOngoing
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment o...
Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Z-2549-2025September 17, 2025Austin, TX
B.Braun Medical S.A.S.
Class IIOngoing
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
Reason: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Z-2528-2025September 17, 2025Chasseneuil du Poitou CEDEX, N/A
Philips Medical Systems Nederland B.V.
Class IIOngoing
IntelliSpace Cardiovascular, Software 8.0.0.4.
Reason: Software issue that results in the display of outdated information.
Z-2543-2025September 17, 2025Eindhoven, N/A
mo-Vis BVBA
Class IOngoing
IDM-ARLITE-R. Electrical wheelchair component.
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair ...
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM...
Z-2449-2025September 10, 2025San Diego, CA
Baxter Healthcare Corporation
Class IOngoing
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that ...
Z-2332-2025September 10, 2025Deerfield, IL
Dexcom, Inc.
Class IOngoing
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom...
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM...
Z-2447-2025September 10, 2025San Diego, CA
Dexcom, Inc.
Class IOngoing
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: De...
Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM...
Reason: Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair ...
Z-2454-2025September 10, 2025Nevele, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2,...
Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.