Medical device recalls Moderate risk

GE Medical Systems Information Technologies Inc recalls MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system…

Recall date
April 25, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1938-2025
FDA classification
Class II
Brand / firm
GE Medical Systems Information Technologies Inc
Sold / distributed
Worldwide - US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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