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.
FDA Recall Z-1938-2025 · Posted 2025-06-10
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Recalling FirmGE Medical Systems Information Technologies Inc
Recall StatusOpen, Classified
Product CodeDSI
Date Initiated2025-04-25
Product Quantity4,277 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.
Firm Action
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 [email protected].
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
Distribution Pattern
Worldwide - US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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