The Recall Desk
HighFDA (Devices)·Z-1938-2025·Announced 2025-06-18

[pending] MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-ba

Pending LLM rewrite. Source: FDA_DEVICE Z-1938-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

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.
Manufacturer
GE Medical Systems Information Technologies Inc

Distribution

Distributed nationwide across the United States.