Revolution CT — Class II medical device recall Z-2004-2021
Completed recall by GE Healthcare, LLC, reported 2021-07-14, distributed nationwide. GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does
| Recall number | Z-2004-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-03-19 |
| Classified | 2021-07-08 |
| Reported by FDA | 2021-07-14 |
| Distributed | Nationwide (US) |
Product
Revolution CT
Reason for recall
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
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-2004-2021. 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.