Recall Z-1210-2015 ยท JAK System, X-Ray, Tomography, Computed
Xoran Technologies, LLC
Xoran MiniCAT X-ray imaging device
| Date | Mar 2, 2015 (initiated Sep 8, 2014) |
| Status | Terminated |
| Reason | Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Xoran Planned Action : A Xoran Technologies service representative will re-measure and perform calibration to correct all affected systems for kVp and dose issues. For the image quality issue, the service representative will mark the black frame and then attempt to reconstruct an adequate image. CDRH also understands that you are continuing your investigation to determine the root cause and a more permanent corrective action for the 3 identified defects. 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 |
| Quantity | 432 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113421 | MINICAT Xoran Technologies, Inc., Jul 11, 2012 |