Recall Z-1938-2025— GE Medical Systems Information Technologies Inc

Name: FDA recall Z-1938-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-25

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems Information Technologies Inc, initiated 2025-04-25. It names one FDA 510(k) clearance: K992637. 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: 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..

Recalling firm: GE Medical Systems Information Technologies Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-04-25
Firm location: Milwaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K992637 — MUSE CARDIOVASCULAR INFORMATION SYSTEMGeneral Electric Medical Systems Information Techn·cleared 1999-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.