GE Medical Systems Information Technologies Inc: Device Recall

Recall #Z-1938-2025 · 04/25/2025

Class II: Risk

Recall Details

Recall Number: Z-1938-2025
Classification: Class II
Product Type: Device
Recalling Firm: GE Medical Systems Information Technologies Inc
Status: Ongoing
Date Initiated: 04/25/2025
Location: Milwaukee, WI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,277 systems

Reason for Recall

The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.

Product Description

MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.

Distribution Pattern

Worldwide - US Nationwide distribution.

Other Recalls by GE Medical Systems Information Technologies Inc

Class II: Risk 04/22/2024

Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.

View all recalls by GE Medical Systems Information Technologies Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.