inforMED
MalfunctionKZF

HEXALUX

Received Aug 26, 2025 · Event occurred Jul 28, 2025

Report 1043572-2025-00080 · MDR key 22897274

Device

Generic name

Hexalux Surgical Light

Manufacturer

Steris Corporation

Catalog number

EXLCEIL

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT. DURING THE TECHNICIAN'S INSPECTION, HE FOUND THAT THE SLOTTED CONE COMPONENT, WHICH SUPPORTS THE CONNECTION BETWEEN THE SPRING ARM AND DROP TUBE, WAS MISSING. AS A RESULT, THE OTHER COMPONENTS HAD COME LOOSE, RESULTING IN THE REPORTED EVENT. THE TECHNICIAN REPAIRED THE HEXALUX SURGICAL LIGHT AND CONFIRMED ALL COMPONENTS WERE PRESENT AND PROPERLY INSTALLED. THE LIGHTING SYSTEM WAS RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR HEXALUX SURGICAL LIGHT DETACHED FROM THE CEILING. NO REPORT OF INJURY.