MalfunctionIXA
AFP
Received Mar 12, 2001
Report MW4002959 · MDR key 320254
Device
Generic name
Soft Film Cassette, 6x12" For Panoramic X-ray System
Manufacturer
Afp Imaging CorpModel number
*Catalog number
857000001
Lot number
*
Product problems
- Design/structure problem
- Leak/Splash
Patient
NA
Narrative
Description of Event or Problem
SOFT FILM CASSETTES FOR PANORAMIC X-RAY SYSTEMS ARE NOT LIGHT TIGHT. X-RAY FILM IS FOGGED WITHIN 5 MINS WHEN CASETTE IS REMOVED FROM THE DARKROOM, COMPLAINANT HAS WORKED WITH SUPPLIER AND HAS DETERMINED THAT 10 UNITS ALL HAD THE SAME PROBLEM. AT THE REQUEST OF AFP, A COMPARISON WAS MADE WITH A COMPETITOR'S (GENDEX) PRODUCT; THE GENDEX PRODUCT WAS LIGHT TIGHT. AFP CASSETTE IS USED WITH LANEX REGULAR SCREENS AND E-MAT-G FILM. THE 6/12" SIZE IS USED ON A KAYKOR PANARAMIC X-RAY SYSTEM.