Canon Solid State X-ray Imager — Class II medical device recall Z-2265-2012
Terminated recall by Canon Inc., reported 2012-09-05, distributed nationwide. Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
| Recall number | Z-2265-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Inc., Tokyo, N/A, Japan |
| Recall initiated | 2010-11-01 |
| Classified | 2012-08-24 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2014-01-07 |
| Distributed | Nationwide (US) |
| Quantity | 468 units |
| Model numbers | 3928B002AA, 3930B002AA, 4066B002AA, CXDI-55C, CXDI-55G, CXDI-70C |
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 for recall
Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2265-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.