FDA recall Z-1938-2025

GE Medical Systems Information Technologies Inc · Class II · device

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.

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-04-25
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Milwaukee, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1938-2025