Proteus XR/a — Class II medical device recall Z-2449-2019
Ongoing recall by GE Healthcare, LLC, reported 2019-10-02, distributed nationwide. Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stat
| Recall number | Z-2449-2019 |
|---|---|
| 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 | 2019-08-09 |
| Classified | 2019-09-20 |
| Reported by FDA | 2019-10-02 |
| Distributed | Nationwide (US) |
| Model numbers | 5441870, 5462233, 5462233-H, 5462233-R, 5761170 |
Product
Proteus XR/a (SlOK : K993090)
Reason for recall
Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
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-2449-2019. 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.