Enforcement Report - Week of October 10, 2012
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Product Detail
| Product Description | EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination. |
|---|---|
| Recall Number | Z-2072-2012 |
| Classification | Class II |
| Code Info | All associated Serial Numbers |
| Product Distributed Qty | 12 EOS Systems installed in the US |
| Reason For Recall | It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode. |
Event Detail
| Event Id | 62621 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Eos Imaging Inc |
| City | Cambridge |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide distribution |
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