Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System |
| Quantity | 9 units installed in US |
| Distribution | Nationwide Distribution including NM, WY, FL, MO, MA, and MI. |
| Initiated | 2012-08-03 |
| Classified | 2013-02-26 |
| Terminated | 2013-12-05 |
| Recall number | Z-0761-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-0761-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64226/
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