HexaLux HexaLux Ceiling Mount (REF EXLCEIL)Recalls & reported problems
Steris · The HexaLux Ceiling-Mount Light is a powerful, next-generation LED exam light designed to be used in a multitude of rooms including the exam room, birthing suite, or intensive care unit. · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995167806), received between Jun 19, 2023 and Apr 19, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Installation-Related Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Laceration(s)1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE SPRING ARM TO THEIR HEXALUX EXAMINATION LIGHT DETACHED, MAKING CONTACT TO THE EMPLOYEE AND PATIENT'S HEAD. ADDITIONALLY, THE PATIENT WAS CONTACTED IN THE FOREARM RESULTING IN AN INJURY (LACERATION). MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED (WOUND CARE). NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Laceration(s)
MAUDE report 19145007 ↗MalfunctionJan 3, 2024Detachment of Device or Device Component; Installation-Related Problem; Detachment of Device or Device Component; Installation-Related Problem
THE USER FACILITY REPORTED THAT THE LIGHT SPRING ARM TO THEIR HEXALUX EXAMINATION LIGHT DETACHED. THE PATIENT WAS NOT PRESENT IN THE ROOM DURING THE TIME OF THE EVENT. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18436741 ↗MalfunctionNov 3, 2023Installation-Related Problem; Installation-Related Problem
THE USER FACILITY REPORTED THAT THE SPRING ARM ON THEIR HEXALUX EXAMINATION LIGHT DETACHED AT THE END OF A PATIENT PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18067708 ↗MalfunctionJun 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR HEXALUX EXAMINATION LIGHT CAME DOWN FROM THE CEILING CONTACTING AN EMPLOYEE'S BACK. THE UNIT DID NOT COMPLETELY DETACH FROM THE CEILING AS THE ELECTRICAL CABLE WAS STILL INTACT. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17152626 ↗
Other Device, medical examination, ac powered devices
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- LUCEA LED® ARDLCA309008AMaquet Sas · Device, Medical Examination, Ac Powered1 recall0 reports
- LUCEA LED® ARDLCA309009AMaquet Sas · Device, Medical Examination, Ac Powered1 recall0 reports
- LUCEA LED® ARDLCA209021AMaquet Sas · Device, Medical Examination, Ac Powered1 recall0 reports
- Hillrom™ 4058110Baxter Medical Systems GmbH + Co. KG · Device, medical examination, ac powered4 reports
- HexaLux HexaLux Ceiling MountSteris Corporation · Device, medical examination, ac powered4 reports
- Chromophare F300 CE2863075Berchtold Holding GmbH · DEVICE, MEDICAL EXAMINATION, AC POWERED2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.