MalfunctionGCT
VISERA 4K UHD XENON LIGHT SOURCE
Received May 19, 2026 · Event occurred May 5, 2026
Report 3002808148-2026-16817 · MDR key 25219902
Device
Product problems
- Poor Quality Image
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE XENON LIGHT SOURCE IMAGE HAD LOW BRIGHTNESS. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.