MUSE Cardiology Information System — Class II medical device recall Z-0919-2022
Terminated recall by GE Healthcare, LLC, reported 2022-04-20. Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in t
| Recall number | Z-0919-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-03-16 |
| Classified | 2022-04-13 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2026-05-04 |
| Countries outside the US | AT, AU, BE, BH, BR, CA, DE, DK, ES, FR, GB, IE, IT, KR, MY, NL, NO, PL, QA, SA, SE, SG, TR, TW |
| Quantity | 147 units |
| UPC / GTIN / UDI-DI | 00840682142809 |
| Serial numbers | SSR19265115TA, SSR19285150TA, SSR19305164TA, SSR19305178TA, SSR19355213TA, SSR19395224TA, SSR19415228TA, SSR19415230TA, SSR19425238TA, SSR19435251TA, SSR19445252TA, SSR19445257TA, SSR19455267TA, SSR19485282TA, SSR19485286TA, SSR19505289TA, SSR19515306TA, SSR19525317TA, SSR20035336TA, SSR20045337TA, SSR20085352TA, SSR20125313TA, SSR20125350TA, SSR20225343TA, SSR20225349TA and 122 more |
Product
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Reason for recall
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
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-0919-2022. 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.