SIGNA Creator — Class II medical device recall Z-0137-2022
Terminated recall by GE Healthcare, LLC, reported 2021-10-27, distributed in AZ, CA, FL, GA, IL, LA, MA, MD…. Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume image
| Recall number | Z-0137-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-08-26 |
| Classified | 2021-10-16 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2026-05-04 |
| Distributed | AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, PR, TX, VA, WA |
| Countries outside the US | AE, AU, BE, CA, CL, CO, DE, ES, FR, GB, IT, JP, KR, PL, SA, SE, TR |
| Quantity | 6 devices |
Product
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Reason for recall
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0137-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.