MalfunctionIYO
DENSHI DIAGNOSTIC ULTRASOUND FF-SONIC UF-4500
Received Jun 18, 1997
Report MW4002078 · MDR key 137188
Device
Generic name
Pulsed Echo Imaging System
Manufacturer
Fukuda Denshi Usa, Inc.Model number
NACatalog number
NA
Lot number
NA
Product problems
- False claim
Patient
NA
Narrative
Description of Event or Problem
COMPLAINT IS A CHIROPRACTOR WHO PURCHASED A DIAGNOSTIC ULTRASOUND UNIT WHICH WAS REPRESENTED AS BEING SUITABLE FOR USE IN DIAGNOSING SPINAL CONDITIONS. THE UNIT, ACCORDING TO THE COMPLAINT, WAS NOT ONLY UNSUITABLE FOR THE TASK BUT ALSO UNAPPROVED FOR THAT USE.