Revolution CT with Apex Edition CT System — Class II medical device recall Z-0695-2021
Terminated recall by GE Healthcare, LLC, reported 2020-12-30, distributed nationwide. A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protoco
| Recall number | Z-0695-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-11-23 |
| Classified | 2020-12-22 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2023-08-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, ES, FR |
| Quantity | 3 units |
| Serial numbers | REVVX1700078CN |
| Model numbers | 5995000-5 |
Product
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason for recall
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
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-0695-2021. 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.