Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body. |
|---|---|
| Recall Number | Z-0198-2013 |
| Classification | Class II |
| Code Info | part numbers: 5555000-5, 5555000-6 |
| Product Distributed Qty | 364 total units installed in US |
| Reason For Recall | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. |
Event Detail
| Event Id | 63597 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | GE Healthcare, LLC |
| City | Waukesha |
| State | WI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution |
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