Class 2 Device Recall Digital Radiography, CXDI

• Date Initiated by Firm: November 01, 2010
• Date Posted: August 24, 2012
• Recall Status: Terminated on January 07, 2014
• Recall Number: Z-2265-2012
• Recall Event ID: 62828
• 510(K)Number: K091435 K091436 K102012
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• 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.
• Code Information: Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.
• Recalling Firm/ Manufacturer: Canon Inc.; 30-2, Shimomaruko 3-chome,; Ohta-ku; Tokyo Japan
• Manufacturer 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: 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 in Commerce: 468 units
• Distribution: Nationwide Distribution (USA)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQB; 510(K)s with Product Code = MQB; 510(K)s with Product Code = MQB