Revolution Apex — Class II medical device recall Z-0306-2021
Terminated recall by GE Healthcare, LLC, reported 2020-11-04, distributed nationwide. There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect
| Recall number | Z-0306-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-09-21 |
| Classified | 2020-10-29 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2022-12-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CN, DK, EE, ES, FI, FR, GB, JP, KW, NO, SA, SE, TH |
| Quantity | 64 devices |
| Model numbers | 5995000-5 |
Product
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason for recall
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
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-0306-2021. 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.