inforMED
MalfunctionKZF

HEXALUX

Received Apr 22, 2026 · Event occurred Mar 26, 2026

Report 1043572-2026-00038 · MDR key 24955423

Device

Generic name

Surgical Light

Manufacturer

Steris Corporation

Catalog number

EXLCEIL

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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

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.