FDA Device recall Z-0816-2022
Revolution CT, Revolution CT ES
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Revolution CT, Revolution CT ES by Ge Healthcare, citing the accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0816-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-30 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Revolution CT, Revolution CT ES
Reason
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
Identifiers
| code_info | Revolution CT, Revolution CT ES |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0816-2022%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.