The Revolution CT is a multi-slice — Class II medical device recall Z-0955-2015
Terminated recall by GE Healthcare, reported 2015-02-04, distributed in CA, FL, IL, NY, UT, WA. A required quality control test was not performed during installation associated with the software of the Revo
| Recall number | Z-0955-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2014-11-12 |
| Classified | 2015-01-26 |
| Reported by FDA | 2015-02-04 |
| Terminated | 2015-04-29 |
| Distributed | CA, FL, IL, NY, UT, WA |
| Quantity | 13 units |
| Reason classes | software |
Product
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
Reason for recall
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
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-0955-2015. 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.