FDA-Device2012-09-05Class II
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.
Canon Inc.
Hazard
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Sold states
Nationwide Distribution (USA)
Affected count
468 units
Manufactured in
30-2, Shimomaruko 3-chome,, Ohta-ku, Tokyo, N/A, Japan
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2012Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief