TruLight 4038310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761995901), received between Jun 10, 2022 and Jun 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Device Fell; Device Fell

  IT WAS REPORTED A TRULIGHT FELL AND INJURED A HEALTHCARE PROFESSIONAL. DURING A PROCEDURE, THE TRULIGHT ¿BECAME DISENGAGED¿ AND ¿FELL ON THE ANESTHESIOLOGIST¿S HEAD.¿ THE EVENT CAUSED AN UNSPECIFIED INJURY TO THE PHYSICIAN. IT WAS LATER CLARIFIED THAT THE ANESTHESIOLOGIST WAS HIT ON THEIR HEAD BY THE MONITOR DROPPING BACK DOWN AFTER BEING PUSHED UP. DETAILS OF THE REPORTED INJURY AND WHETHER ANY MEDICAL INTERVENTION WERE REQUIRED WERE NOT FURTHER SPECIFIED. AN INSPECTION PERFORMED BY A THIRD-PARTY TECHNICIAN NOTED THAT THE DEVICE ARM WAS DROPPING DUE TO PLEXIGLASS SCREEN PROTECTORS ADDED BY THE FACILITY¿S BIOMED. THESE SCREENS ADDED EXTRA WEIGHT TO THE ARMS, WHICH CAUSED THE MONITOR TO SLOWLY DRIFT. THE FIELD SERVICE TECHNICIAN SET THE MAX TENSION ON THE SPRING ARMS TO ENSURE THAT THE SPRING ARMS DO NOT DRIFT. ADDITIONALLY, THE EVENT WAS LIKELY DUE TO A USER ERROR/MISUSE OF THE DEVICE, AS THE CUSTOMER DID NOT INFORM BAXTER NOR THE THIRD-PARTY TECHNICIAN OF THE DEVICE MODIFICATION PERFORMED THAT CAUSED THE MONITOR TO DRIFT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Head Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293424 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS ALLEGED THE LIGHT HEAD DETACHED FROM THE SUPPORT ARM SYSTEM AND FELL TO THE SIDE OF THE OPERATING TABLE DURING A SURGICAL PROCEDURE. THE LIGHT HEAD HIT A NURSES ELBOW DURING THE FALL CAUSING TRAUMA TO HER ARM. THE NURSE WAS IMMEDIATELY ACCOMPANIED TO THE EMERGENCY ROOM WITH A PROGNOSIS OF 8 DAYS. FOLLOW-UP ATTEMPTS WERE MADE WITH THE CUSTOMER. HOWEVER; NO FURTHER DETAILS OF THE EMPLOYEE INJURY DIAGNOSIS, MEDICAL INTERVENTION AND EMPLOYEE OUTCOME WERE PROVIDED YET. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14657708 ↗