FDA Device recall Z-0858-2022
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System by Ge Healthcare, citing there is potential for the images to be flipped left to right.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0858-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-18 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
Reason
There is potential for the images to be flipped left to right.
Identifiers
| code_info | System IDs: 928223MR3T, 360397MR2, 602406IMR, 480323MR1, 928SMIMR, 3825, 559325CIIMR1, 805988MR2, 6617263TMR, 650306SM…System IDs: 928223MR3T, 360397MR2, 602406IMR, 480323MR1, 928SMIMR, 3825, 559325CIIMR1, 805988MR2, 6617263TMR, 650306SMR3T, 4036, 3600, 3266, 818RIMR3T, 4267, 352333MR3T, 407SOMR3T, 941PCMR, 386HPOMR, ALLIANCESIG463, 337261MR1, 601288MR3T, 662841MR4, 336713WFUMR, 609383MR, 201487MR, 805998MR1, 805998CR1, 702369SM3TLV, 405634S3T, 814234MR, 6053883T, 731425MR2, 901425MROP1, 806212MR3T, 409892SMR2, 972566MR3, 972378NSC3TMR1, 801377MR2, 910277003, 2577595, 082427090088, 082427210045, 082427270017, 082427160041, 082427040047, 082427040052, 082427040074, 082427210039, 082427090090, 082427310027, 082427100093, 082427140039, 082427030039, 082427100099, 082427100084, 082427070050, 082427070034, 082427310019, 082427100089, IR1503MR01, A5125121, A5806911, YM3034, 850270175, 850270176, 850270199, 850270361, 850270205, KW1004MR03, RF0754MR01, GEE34040, 0853270071, 0853270072, 34208MRS01, 34006MRS03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Ge Healthcare
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Adminis…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise im…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0858-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.