GE Healthcare Revolution XR/d — Class II medical device recall Z-1788-2012
Terminated recall by General Electric Med Systems LLC, reported 2012-06-20. An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tablet
| Recall number | Z-1788-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | General Electric Med Systems LLC, Waukesha, WI, United States |
| Recall initiated | 2006-05-31 |
| Classified | 2012-06-08 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2012-07-31 |
| Quantity | 3,796 units |
| Model numbers | 2259988-2, 2351505 |
Product
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
Reason for recall
An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
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-1788-2012. 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.