GE Healthcare Revolution CT — Class II medical device recall Z-0985-2015
Terminated recall by GE Healthcare, reported 2015-01-21, distributed in CA, FL, IL, NY, UT, WA. Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No
| Recall number | Z-0985-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-01-15 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-04-29 |
| Distributed | CA, FL, IL, NY, UT, WA |
| Countries outside the US | AE, CA, CH, FR, HK, JP |
Product
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Reason for recall
Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
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-0985-2015. 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.