Recall Z-1938-2025
GE Medical Systems Information Technologies Inc · initiated April 25, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial Numbers: ABF04400266FA SAD04390481GA SAD05091885GA SAD05091907GA SAD05091908GA PA2155054 PA2155057 PA2155059 PA2155061 PA2155063 SAD05302639GA SAD05302646GA SAD05322687GA SAD05322723GA SAD05322735GA SAD06524784GA SAD06204075GA SAD06204076GA SAD06204077GA SAD04380416GA SAD04380427GA SAD04430607GA SAD04440716GA SAD04440717GA SAD04440718GA SAD04440719GA SAD05453127GA SAD05453128GA SAD05453129GA SAD05453130GA SAD05453172GA SAD08105319GA SAD08105320GA SAD04501236GA SAD04501237GA SAD04501252GA SAD04501257GA SAD04501258GA SAD04350305GA SAD04350317GA SAD04350318GA SAD04350319GA SAD04350320GA SAD04350326GA SAD06424592GA SAD06444630GA SAD06454662GA SAD04491128GA SAD04491129GA SAD04491130GA SAD04491131GA SAD04491132GA SAD04491151GA SAD04501216GA SAD04501217GA SAD04501218GA SAD04501220GA SAD04501221GA SAD04501222GA SAD04501223GA SAD04501224GA SAD04501225GA SAD04501226GA SAD04501227GA SAD04501228GA SAD04501229GA PA2020935 PA2020936 SAD05081763GA SAD05081836GA SAD05091867GA SAD05091868GA SAD0932 SAD09335621GA SAD09335622GA SAD05302635GA SAD06344526GA SAD05091896GA SAD05091905GA SAD05091906GA SAD06424610GA SAD06444638GA SAD06194039GA SAD06194040GA SAD06194041GA SAD05172239GA…
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.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-1938-2025
- Initiated
- April 25, 2025
- Posted by FDA
- June 10, 2025
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Quantity
- 4,277 systems
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- GE Medical Systems Information Technologies Inc, Milwaukee, WI