FDA Recall
Terminated
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.
Recall: Z-2265-2012
·
Initiated November 1, 2010
Recall
- Recall Number
- Z-2265-2012
- Event Number
- 62828
- Firm
- Canon Inc. 30-2, Shimomaruko 3-chome, Ohta-ku Tokyo Japan
- FEI Number
- 1000181430
- Product Code
- MQB
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 1, 2010
- Posted
- August 24, 2012
- Terminated
- January 7, 2014
Description
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.
Reason
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
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.
Distribution
Nationwide Distribution (USA)
Quantity
468 units