Recall Z-2072-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Eos Imaging Inc
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
| Date | Sep 28, 2012 (initiated Jun 19, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | EOS Imaging notified users by letter on 6/19/12 and that an on site correction would be performed by an EOS Imaging Field Service engineer. EOS indicated in its notification that although this specific defect has not been observed in EOS systems installed in the U.S, they will replace the anode driver boards with new boards equipped with high current capacitors. Similarly, the generator firmware will be upgraded with the software patch that improves the cooling fans' controls. This will be replaced at no charge to the customers, during regularly scheduled preventative maintenance of the use |
| Quantity | 12 EOS Systems installed in the US |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.