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Terminated

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.

FDA Recall Z-2265-2012 · Posted 2012-08-24

Recalling FirmCanon Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-11-01
Date Terminated2014-01-07
Product Quantity468 units

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution (USA)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102012DIGITAL RADIOGRAPHYCanon Inc. -Medical Equipment Group · 2010-08-17K091435DIGITAL RADIOGRAPHY MODEL CXDI-55GCanon, Inc. · 2009-05-29K091436DIGITAL RADIOGRAPHY, MODEL CXDI-55CCanon, Inc. · 2009-05-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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