GE Healthcare Proteus XR/a with wall stand model number 2260354 — Class II medical device recall Z-1248-2015
Terminated recall by GE Healthcare, reported 2015-03-18, distributed nationwide. Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X
| Recall number | Z-1248-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-01-30 |
| Classified | 2015-03-06 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2015-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CA, CL, CZ, DE, ES, FR, GB, GR, HK, HU, IE, IT, JP, NZ, PT, RU, SA, SK |
| Reason classes | device malfunction |
| Model numbers | 2260354 |
Product
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Reason for recall
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
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-1248-2015. 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.