Recall Z-0529-2014 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
EOS Imaging
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
| Date | Jan 9, 2014 (initiated Nov 7, 2013) |
| Status | Terminated |
| Reason | EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition. |
| Root cause | Device Design |
| Action | CDRH approves the following conditions for EOS Imaging SA: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator notes below what are to be included in the notification. The draft letter provided on November 28, 2013, is deficient for the following reasons: a. It does not provide a statement that all repairs will be made without charge (21 CFR 1003.21(3)). b. It does not provide instructions, with respe |
| Quantity | 22 EOS systems are installed in 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.