FDA Medical Device Recalls (openFDA)
Canon Inc.: 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.
- Recall number
- Z-2265-2012
- 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.
- Status
- Terminated
- Initiated
- 2010-11-01
- Posted
- 2012-08-24
- Terminated
- 2014-01-07
- Reason
- Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
- 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
- 468 units
- Distribution
- Nationwide Distribution (USA)
- Lot, serial or model codes
- Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.
- 510(k) numbers
- ["K091435","K091436","K102012"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 1000181430
- Firm city
- Ohta-ku
- Firm state
- Tokyo
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28