GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System — Class II medical device recall Z-0761-2013
Terminated recall by GE Healthcare, LLC, reported 2013-03-06, distributed nationwide. GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 rad
| Recall number | Z-0761-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-08-03 |
| Classified | 2013-02-26 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 9 units |
| Reason classes | software |
| Model numbers | 5271997 |
Product
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Reason for recall
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
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-0761-2013. 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.