Z-2265-2012Class II

Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G...

Name: Z-2265-2012 Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G...
Creator: Canon Inc.
Published: 2010-11-01
License: https://open.fda.gov/license/

Canon Inc. / initiated 2010-11-01 / Terminated / root cause: manufacturing process

FDA source

Canon Inc. began a recall of 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... on 2010-11-01. FDA classified it as Class II and gives the reason as "Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2265-2012
Classification: Class II
Status: Terminated
Initiated: 2010-11-01
Posted: 2012-08-24
Terminated: 2014-01-07
Recalling firm: Canon Inc.
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 468 units
Distribution: Nationwide Distribution (USA)
Product codes and lots: Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2265-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2265-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-24

Product code MQB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)