FDA Device recall Z-2004-2021
Revolution CT
- FDA Device
- Class II
- completed
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Revolution CT by Ge Healthcare, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2004-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-03-19 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Revolution CT
Reason
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.
Identifiers
| code_info | 5590000 5590000-6 5590000-2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2004-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.