FDA Device recall Z-0761-2013
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
- FDA Device
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0761-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-03 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Reason
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.
Identifiers
| code_info | Model Number : 5271997 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0761-2013%22
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