Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C.
FDA device recall Z-2265-2012 · posted 2012-08-24 · Terminated
Recall details
- Recalling firm
- Canon Inc.
- Reason for recall
- Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
- Action taken
- 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
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 468 units
- Distribution
- Nationwide Distribution (USA)
- Date initiated
- 2010-11-01
- Date posted
- 2012-08-24
- Date terminated
- 2014-01-07
- Location
- Ohta-ku, Tokyo, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIGITAL RADIOGRAPHY (K102012) | Canon Inc. -Medical Equipment Group | 2010-08-17 |
| DIGITAL RADIOGRAPHY MODEL CXDI-55G (K091435) | Canon, Inc. | 2009-05-29 |
| DIGITAL RADIOGRAPHY, MODEL CXDI-55C (K091436) | Canon, Inc. | 2009-05-29 |