GE Proteus XR/A radiographic system — Class II medical device recall Z-0550-2025
Ongoing recall by GE Healthcare (China) Co., Ltd., reported 2024-12-04, distributed nationwide. Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replac
| Recall number | Z-0550-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare (China) Co., Ltd., Beijing, China |
| Recall initiated | 2024-10-24 |
| Classified | 2024-11-25 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 956 systems |
| UPC / GTIN / UDI-DI | 00082407040377, 00840682120777 |
Product
GE Proteus XR/A radiographic system
Reason for recall
Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
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-0550-2025. 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.