Revolution Apex — Class II medical device recall Z-0815-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-04-13, distributed nationwide. The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result
| Recall number | Z-0815-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-06-30 |
| Classified | 2022-04-05 |
| Reported by FDA | 2022-04-13 |
| Distributed | Nationwide (US) |
Product
Revolution Apex, Revolution CT with Apex Edition
Reason for recall
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
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-0815-2022. 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.