Data Foundry

Medical device recalls 2025

MUSE 5 Systems — Class II medical device recall Z-1938-2025

Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2025-06-18, distributed nationwide. The MUSE Administrator Account active directory or local credential could potentially be used from your local

Recall numberZ-1938-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Medical Systems Information Technologies Inc, Milwaukee, WI, United States
Recall initiated2025-04-25
Classified2025-06-10
Reported by FDA2025-06-18
DistributedNationwide (US)
Quantity4,277 systems
Serial numbersABF04130165FA, ABF04290227FA, ABF04340232FA, ABF04350237FA, ABF04350238FA, ABF04360243FA, ABF04380255FA, ABF04380256FA, ABF04380257FA, ABF04380258FA, ABF04390264FA, ABF04400266FA, ABF04450276FA, ABF04450277FA, ABF04460279FA, ABF04480282FA, ABF04480283FA, ABF04500295FA, ABF04500296FA, ABF05010305FA, ABF05010306FA, ABF05010307FA, ABF05070319FA, ABF05090321FA, ABF05110329FA and 475 more
Model numbers2021274-001, 2023032-005, 2027478-001

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1938-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.