Enforcement Report - Week of June 20, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-1788-2012 |
| Classification | Class II |
| Code Info | all serial numbers |
| Product Distributed Qty | 3,796 units |
| 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 |
Event Detail
| Event Id | 37654 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | General Electric Med Systems LLC |
| City | Waukesha |
| State | WI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2006-05-31 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution. |
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