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iLED 4028110Recalls & reported problems

Baxter Medical Systems GmbH + Co. KG · Hospital Device · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761995963), received between Jul 8, 2020 and Oct 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Flaked” (2 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.

Most reported problems

Device problems

  • Flaked2
  • Degraded1
  • Material Integrity Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 1, 2021Flaked; Flaked

    THE CUSTOMER ALLEGED THAT PAINT IS FALLING DOWN FROM THE SURGICAL LIGHT. NO INJURY OR IMPACT TO ANY SURGICAL PROCEDURE WAS REPORTED IN RELATION TO THIS ALLEGATION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12565705 ↗
  • MalfunctionJul 8, 2020Degraded; Flaked; Material Integrity Problem; Degraded; Flaked; Material Integrity Problem

    THE CUSTOMER ALLEGED THE PAINT IS CHIPPING FROM THE LIGHT HEAD HANDLES. NO PATIENT OR CAREGIVER INJURY WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 10244448 ↗

Other Light, surgical, instrument devices

All Light, surgical, instrument devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.