Revolution CT scanners Product Usage: The system is intended for head — Class II medical device recall Z-1951-2019
Ongoing recall by GE Healthcare, LLC, reported 2019-07-24, distributed nationwide. Additional low dose radiation exposure.
| Recall number | Z-1951-2019 |
|---|---|
| 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 | 2019-01-19 |
| Classified | 2019-07-12 |
| Reported by FDA | 2019-07-24 |
| Distributed | Nationwide (US) |
Product
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason for recall
Additional low dose radiation exposure.
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-1951-2019. 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.