MalfunctionLMB
FUJI SYNOPSE
Received Apr 13, 2002 · Event occurred Jan 9, 2002
Report 2443168-2002-00001 · MDR key 388339
Device
Generic name
Pacs System
Manufacturer
Fujifilm Medical System U.s.a., Inc.Model number
VERSION 2.0.2Catalog number
NA
Lot number
NA
Product problems
- Image Orientation Incorrect
Patient
NO INFO
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
WHEN A FACILITY REPRINTED A CT EXAM DEMONSTRATING RIGHT SINUS OCCLUSION ONE MONTH AFTER THE EXAM, A PHYSICIAN NOTICED THE SIDE OF THE OCCLUSION WAS MARKED (INCORRECTLY) AS THE LEFT SIDE. THE FACILITY REPRINTED THE STUDY A SECOND TIME AND THE ORIGINAL CORRECT ORIENTATION APPEARED. THE FACILITY COULD NOT REPRODUCE THE PROBLEM ON FURTHER REPRINTING.
Remedial action
- Notification
- Other