Enforcement Report - Week of December 5, 2012
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Product Detail
| Product Description | GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). |
|---|---|
| Recall Number | Z-0450-2013 |
| Classification | Class II |
| Code Info | Model No - 5421698 |
| Product Distributed Qty | 217 total installed in the US |
| Reason For Recall | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade. |
Event Detail
| Event Id | 63212 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | GE Healthcare, LLC |
| City | Waukesha |
| State | WI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-01 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution |
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