Z-2265-2012 Class II Terminated
FDA device recall Z-2265-2012 was initiated by Canon Inc. on November 1, 2010 and is designated Class II. Reason for recall: Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. The recall status is terminated (terminated January 7, 2014). Affected quantity: 468 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2012
- Initiation Date
- November 1, 2010
- Termination Date
- January 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 468 units
Product 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 for Recall
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Distribution Pattern
Nationwide Distribution (USA)
Code Information
Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.