Recall Z-2265-2012
Canon Inc. · initiated November 1, 2010
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.
Reason for recall
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2265-2012
- Initiated
- November 1, 2010
- Posted by FDA
- August 24, 2012
- Terminated
- January 7, 2014
- Product code
- MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Quantity
- 468 units
- Distribution
- Nationwide Distribution (USA)
- Recalling firm
- Canon Inc., Ohta-ku, Tokyo