Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body. |
|---|---|
| Recall Number | Z-2256-2012 |
| Classification | Class II |
| Code Info | Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6. |
| Product Distributed Qty | 254 total in the US |
| Reason For Recall | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed. |
Event Detail
| Event Id | 62946 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | GE Healthcare, LLC |
| City | Waukesha |
| State | WI | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-10 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution -- USA (nationwide) Distribution |
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