Recall Z-1938-2025 ยท DSI Detector And Alarm, Arrhythmia
GE Medical Systems Information Technologies Inc
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.
| Date | Jun 10, 2025 (initiated Apr 25, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| 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 ar |
| Quantity | 4,277 systems |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992637 | MUSE CARDIOVASCULAR INFORMATION SYSTEM General Electric Medical Systems Information Techn, Nov 3, 1999 |