Recall Z-2265-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Canon Inc.
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
| Date | Aug 24, 2012 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. |
| Root cause | Nonconforming Material/Component |
| Action | Canon Inc. notified sales companies including Canon USA on 9/15/2010 with Service Bulletin 10-017, and on 8/25/2011 with Service Bulletin 11-011, and on 1/20/2011 with Service Bulletin 11-001. Sales representatives were to visit customers and check and replace the screws. |
| Quantity | 468 units |
| Distribution | Nationwide Distribution (USA) |
| FDA record | Open on fda.gov |