FDA Device recall Z-0815-2022
Revolution Apex, Revolution CT with Apex Edition
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Revolution Apex, Revolution CT with Apex Edition 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-0815-2022 |
| 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 Apex, Revolution CT with Apex Edition
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 Apex, Revolution CT with Apex Edition |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0815-2022%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.