MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system

FDA device recall Z-1938-2025 · posted 2025-06-10 · Open, Classified

Recall details

Recalling firm

GE Medical Systems Information Technologies Inc

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.

Action taken

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 4/25/25 was sent to customers. Actions to be taken by Customer/User: MUSE 5 systems have reached their End of Sales/Service Support as of November 1, 2014. Please see attached for the End of Sales/Service Support letter that was previously distributed. GE HealthCare recommends that customers replace or upgrade these systems. If you wish to continue using your MUSE 5 system, you should ensure your IT Department provides ongoing prevention of unauthorized access to the system such as not using a well-known password. If passwords are well-known, please update the credentials according to your organization's password policies or contact GE HealthCare Service or your local Service Representative if necessary. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached Medical Device Notification Acknowledgement Response Form to DCAR.Recall@gehealthcare.com. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Software design

Status

Open, Classified

Product code

DSI

Quantity affected

4,277 systems

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2025-04-25

Date posted

2025-06-10

Location

Milwaukee, WI

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