Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C,...
FDA Recall #Z-2265-2012 — Class II — November 1, 2010
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.
Recalling Firm
Canon Inc. — Tokyo, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
468 units
Distribution
Nationwide Distribution (USA)
Code Information
Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated