Recall Z-2265-2012— Canon Inc.

Name: FDA recall Z-2265-2012
Creator: U.S. Food and Drug Administration
Published: 2010-11-01

Class II · Terminated

Class II FDA medical device recall by Canon Inc., initiated 2010-11-01, terminated 2014-01-07. It names 3 FDA 510(k) clearances: K102012, K091435, K091436. 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.. Reason: Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor..

Recalling firm: Canon Inc.
Classification: Class II
Status: Terminated
Initiated: 2010-11-01
Terminated: 2014-01-07
Firm location: Tokyo, N/A, Japan

510(k) clearances named in this recall

3 on FDA's record

K102012 — DIGITAL RADIOGRAPHYCanon Inc. -Medical Equipment Group·cleared 2010-08-17
K091435 — DIGITAL RADIOGRAPHY MODEL CXDI-55GCanon, Inc.·cleared 2009-05-29
K091436 — DIGITAL RADIOGRAPHY, MODEL CXDI-55CCanon, Inc.·cleared 2009-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.