CLASS II Device recall · Reported 5 Sep 2012 · FDA Enforcement Report
Solid State X-ray Imager (Flat Panel/Digital Imager) recalled by Canon
Canon is recalling Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, distributed nationwide in the US. The recall was initiated on 1 Nov 2010 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2265-2012
- FDA event ID
- 62828
- Recalling firm
- Canon, Tokyo, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2010
- FDA classified
- 24 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 1 Nov 2010 | Recall initiated by company | |
| 24 Aug 2012 | Classified by FDA | +662 days |
| 5 Sep 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution (USA)
Questions about this recall
Is Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography recalled?
Yes. Canon recalled Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography on 1 Nov 2010. The recall is Class II and its status is Terminated. Recall number Z-2265-2012.
Why was it recalled?
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Which lots are affected?
Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.
Where was it sold?
Nationwide Distribution (USA)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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