FDA Adverse Event
Malfunction
Summary report: N
DIGITAL RADIOGRAPHY CXDI-70C WIRELESS
MDR report key: 2665212
·
Received July 12, 2012
Report
- Report Number
- 1000181430-2012-00031
- Event Type
- Malfunction
- Date Received
- July 12, 2012
- Date of Event
- March 15, 2011
- Report Date
- July 9, 2012
- Manufacturer
- CANON INC.
- Product Code
- MQB
- PMA / PMN Number
- K102012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CANON INC RELEASED A NEW FIRMWARE VERSION IN WHICH THE DEFECT IN QUESTION SHOULD HAVE BEEN CORRECTED.
Description of Event or Problem · 1
CANON U.S.A., INC RECEIVED A REPORT THAT IMAGES OUTPUT BY TABS ARE EACH DISPLAYED WITH THIS BACKS AND FRONTS REVERSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL RADIOGRAPHY CXDI-70C WIRELESS | SOLID STATE X-RAY IMAGER | MQB | CANON INC. | CXDI-70C WIRELESS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |