FDA Adverse Event
Malfunction
Summary report: N
DIGITAL RADIOGRAPHY CXDI-55C
MDR report key: 2680756
·
Received July 25, 2012
Report
- Report Number
- 1000181430-2012-00036
- Event Type
- Malfunction
- Date Received
- July 25, 2012
- Date of Event
- May 31, 2011
- Report Date
- July 19, 2012
- Manufacturer
- CANON, INC.
- Product Code
- MQB
- PMA / PMN Number
- K091436
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CANON INC. RELEASED A NEW FIRMWARE VERSION ((B)(4)) IN WHICH THE DEFECT IN QUESTION HAS BEEN CORRECTED.
Description of Event or Problem · 1
CANON U.S.A., INC. HAS RECEIVED A NUMBER OF SERVICE CALLS REGARDING INTERMITTENT REPORTS OF REVERSED BANDS OF IMAGE DATA. INFORMATION/IMAGES ARE READING LEFT TO RIGHT; THE NEXT TAB, THE INFORMATION IS READING BACKWARDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIGITAL RADIOGRAPHY CXDI-55C | SOLID STATE X-RAY IMAGER | MQB | CANON, INC. | CXDI-55C | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NOT AVAILABLE. |