FDA Device recall Z-0133-2022
SIGNA Architect nuclear magnetic resonance imaging system
- FDA Device
- Class II
- terminated
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of SIGNA Architect nuclear magnetic resonance imaging system by Ge Healthcare, citing under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0133-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-26 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, PR, TX, VA, WA |
Product
SIGNA Architect nuclear magnetic resonance imaging system
Reason
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Identifiers
| code_info | Software version DV29.1; and DV28.4 (F), DV27.3 (T) (China only) |
|---|
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-0133-2022%22
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