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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Radiography, CXDI

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 Class 2 Recall
Digital Radiography, CXDI
see related information
Date Posted August 24, 2012
Recall Status1 Terminated on January 07, 2014
Recall Number Z-2265-2012
Recall Event ID 62828
Premarket Notification
510(K) Numbers
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
Manufacturer Reason
for Recall
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = CANON INC.
510(K)s with Product Code = MQB and Original Applicant = CANON, INC.
510(K)s with Product Code = MQB and Original Applicant = CANON, INC.-MEDICAL EQUIPMENT GROUP
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