inforMED
MalfunctionIXL

DIAGNOST 56/66/76

Received Jan 14, 2008 · Event occurred Sep 18, 2007

Report 1217116-2008-00006 · MDR key 980018

Device

Generic name

Ixl - (general Purpose R/f System)

Model number

9870-694-12172

Catalog number

NA

Lot number

NA

Product problems

  • Display or Visual Feedback Problem

Patient

NA

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR RADIOLOGY MANUFACTURER IN ANOTHER COUNTRY, OF AN EVENT THAT OCCURRED. AFTER IMPLEMENTATION OF A NEW DIGITAL SPOT FILM IMAGING (DSI) RELEASE, A CUSTOMER COMPLAINS ABOUT A MISMATCH OF PATIENT DATA AND IMAGES DURING VIEWING AND PRINTOUT. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

THE ROOT CAUSE IS A DESIGN PROBLEM IN THE D2IPB CIRCUIT BOARD.