TruLight 4038210Recalls & reported problems
Baxter Medical Systems GmbH + Co. KG · Hillrom™ TruLight 5000 / 3000 Ceiling Duo · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887761995918), received between Mar 9, 2022 and Feb 13, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Bruise/Contusion1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED DAMAGE TO THE SKY LAMP DURING CLEANING. THE LAMP DETACHED FROM THE JOINT AND CAUSED DAMAGE TO THE CEILING AND FLOOR. NO HARM OR INJURY TO PATIENT OR CAREGIVER WAS REPORTED THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21376787 ↗MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED THAT THEY SAW A SCREW OF THE MONITOR BRACKET LOOSE. WHEN THEY MOVED THE BRACKET, THE MONITOR BRACKET BROKE, THE MONITOR CAME LOOSE AND BURST THE FIBER OPTIC CABLES. NO HARM OR INJURY TO PATIENT OR CAREGIVER WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20245805 ↗MalfunctionFeb 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED THE LIGHT HEAD FELL TO THE FLOOR AND THE SPRING ARM HIT THE CEILING AFTER ONE STAFF MEMBER PULLED THE CLIP OUT OF THE CONNECTION. NO HARM OR INJURY TO PATIENT OR CAREGIVER WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629136 ↗MalfunctionJul 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE SPRING ARM FROM THE LIGHT SYSTEM DETACHED FROM THE CENTRAL AXIS. IT DID NOT FALL DOWN. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17377023 ↗MalfunctionMar 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A NURSE MOVED THE SPRING ARM WITH RADIATION PROTECTION SHIELD WHICH WAS ATTACHED TO THE TRULIGHT SURGICAL LIGHT AS THE SPRING ARM SEPARATED FROM THE SUPPORT ARM SYSTEM AND FELL DOWN. THE FALLING COMPONENT HIT THE NURSE AT THE SHOULDER. NO SERIOUS INJURY OCCURRED IN RELATION TO THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: Bruise/Contusion
MAUDE report 13715002 ↗
Other Light, surgical, instrument devices
- iLED7 Surgical Light 4068210Baxter Medical Systems GmbH + Co. KG · Light, surgical, instrument1 recall3 reports
- iLED7 Surgical Light 4068140Baxter Medical Systems GmbH + Co. KG · Light, surgical, instrument1 recall0 reports
- iLED 4028310Baxter Medical Systems GmbH + Co. KG · Light, surgical, instrument9 reports
- iLED 4028110Baxter Medical Systems GmbH + Co. KG · Light, surgical, instrument2 reports
- SPOTLIGHT 282950900Depuy Spine, LLC · Light, surgical, instrument1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.