FDA Adverse Event Malfunction Summary report: N

DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

MDR report key: 2698466 · Received July 31, 2012

Report

Report Number
1000181430-2012-00040
Event Type
Malfunction
Date Received
July 31, 2012
Date of Event
March 21, 2012
Report Date
July 31, 2012
Manufacturer
CANON INC.
Product Code
MQB
PMA / PMN Number
K102012
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CANON INC. RELEASED A NEW FIRMWARE VERSION IN WHICH THE DEFECT IN QUESTION HAS BEEN CORRECTED.

Description of Event or Problem · 1

CANON U.S.A., INC WAS NOTIFIED THAT A CUSTOMER REPORTED SCRAMBLED IMAGES.

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 NOT AVAILABLE

Patients

Seq Age Sex Outcome Treatment
1 NOT AVAILABLE