FDA Device recall Z-0919-2022
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
- FDA Device
- Class II
- terminated
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008 by Ge Healthcare, citing two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0919-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-16 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Reason
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
Identifiers
| code_info | a) 3101011-040, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR20435644TA, SSR20085352TA, SSR19455267TA, SSR2…a) 3101011-040, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR20435644TA, SSR20085352TA, SSR19455267TA, SSR20245386TA, SSR20225354TA, SSR20235322TA, SSR19485286TA, SSR20265441TA, SSR20435653TA, SSR20235349TA, SSR20315513TA, SSR20045337TA, SSR19415230TA, SSR19425238TA; UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR19305164TA, SSR21255865TA, SSR20525351TA, SSR20525347TA, SSR20325524TA, SSR21326015TA, SSR21025368TA, SSR21065487TA, SSR19395224TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR19445252TA, SSR21035400TA, SSR21536318TA, SSR22056438TA, SSR20225343TA, SSR20515315TA, SSR20265429TA, SSR20465706TA, SSR20315501TA b) 3101010-401, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR19305178TA, SSR19265115TA, SSR20315505TA, SSR20405600TA, SSR20415608TA, SSR20255413TA, SSR20385590TA, SSR20265439TA, SSR19485282TA, SSR19435251TA, SSR20235360TA, SSR20125313TA, SSR20325529TA, SSR20125350TA, SSR19445257TA, SSR20035336TA, SSR19515306TA, SSR19415228TA, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0919-2022%22
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