FDA Device recall Z-0859-2022
SIGNA Excite 3T. 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 SIGNA Excite 3T. 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-0859-2022 |
| 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
SIGNA Excite 3T. Magnetic Resonance Imaging System
Reason
There is potential for the images to be flipped left to right.
Identifiers
| code_info | System IDs: 3422, 209577MRMOBX, 407303CHMR, SIMONVILLAGES3T, 321MR3T3, 321MR3T2, 407999MR3T, 316268TWIN3, 8109873T, 73…System IDs: 3422, 209577MRMOBX, 407303CHMR, SIMONVILLAGES3T, 321MR3T3, 321MR3T2, 407999MR3T, 316268TWIN3, 8109873T, 732473MR, 702433SIM3T, 864573MBMR2, 901726OPMR, 214879INVIVO, 817578LGMR2, 972665XDDAMR1 2284SIG15T, 47413, 2550000, 975, 604270MR3T, 416813MR3, 416369MR2, 082427130025 082427130020, 082427130022, 082427270012, 082427270011, 082427150025, 082427020020, 082427010032, 082427160051, 082427160050, 082427120042, 082427120027, 082427030037, 082427250016, 082427070046, 082427150026, 082427090035, 082427140034, 082427140040, 082427090044, 082427100075, 082427120029, 082427070049, 082427070048, 082427220010, 082427300008, YM1408, YM1414, YM1406, 850270152, LB1049MR02, PK1184MR01 |
|---|
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-0859-2022%22
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