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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0858-2022%22
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