Revolution EVO — Class II medical device recall Z-1900-2021
Ongoing recall by GE Healthcare, LLC, reported 2021-07-07. Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
| Recall number | Z-1900-2021 |
|---|---|
| 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 | 2021-06-14 |
| Classified | 2021-06-25 |
| Reported by FDA | 2021-07-07 |
| Quantity | 3,665 |
| Reason classes | software |
Product
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Reason for recall
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
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-1900-2021. 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.