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Recall Observatory FDA recall evidence

Device 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.

Z-2265-2012

November 01, 2010

Class II

Product summary

Firm
Canon Inc.
Event
Event 62828
Status
Terminated
Classification
Class II
Quantity
468 units
Official record key
device-enforcement:Z-2265-2012

Official wording

Reason: Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.

Code information: Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.

Distribution pattern: Nationwide Distribution (USA)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.