MalfunctionIWZ
MICROVISION CI
Received Mar 31, 2000 · Event occurred Feb 21, 2000
Report 1063474-2000-00001 · MDR key 272559
Device
Generic name
Radiographic Film
Manufacturer
Agfa Corp.Model number
592Catalog number
*
Lot number
9091-0341-04, 9081-0584-01
Product problems
- Signal Artifact/Noise
- Calcified
- False Positive Result
Patient
*
Narrative
Description of Event or Problem
THE FILM REPORTEDLY EXHIBITED LOW DENSITY ARTIFACTS WHICH SUPPOSEDLY COULD RESEMBLE MICRO-CALCIFICATIONS.