Enforcement Report - Week of November 28, 2012
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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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body. | part number: 5421698 | Class II | 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. | 364 total units installed in US | Z-0197-2013 |
| GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body. | part numbers: 5555000-5, 5555000-6 | Class II | 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. | 364 total units installed in US | Z-0198-2013 |
| GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body. | part numbers: 5555000-3, 5555000-4 | Class II | 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. | 364 total units installed in US | Z-0199-2013 |
| GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body. | part numbers:5555000, 5555000-2 | Class II | 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. | 364 total units installed in US | Z-0200-2013 |
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