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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62828
Product Type Devices
Status Ongoing
Recalling Firm Canon Inc.
City Tokyo
Country JP
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-11-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution (USA)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Canon Solid Stale X-ray Imaqer (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. Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA. Class II Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. 468 units Z-2265-2012