Events

Recall of Device Recall ILED Surgical Light

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trumpf Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51236
  • Event Risk Class
    Class 2
  • Event Number
    Z-1122-2009
  • Event Initiated Date
    2009-02-27
  • Event Date Posted
    2009-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79361
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ceiling Mounted Surgical Light - Product Code FSY
  • Reason
    Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.
  • Action
    Consignees were notified via an Urgent Safety Information letter starting 02/27/2009. The Recall Notice asks customers to visually inspect the ILED covers for cracks and in particular to focus on the corners. If cracking is visible they are asked to remedy by taping with a clear tape over the cracks and report it to TRUMPF Medical Systems, Inc. immediately. TRUMPF will be replacing all covers with a newly designed and tested cover. Original priority in the United States will be set to start with the oldest units affected. If TRUMPF receives notification that cracking does exist then that facility will rise to the highest priority. Additionally, TRUMPF will issue a new approved cleaning and disinfection instruction, since investigations have shown that the cracking is significantly influenced by the use of certain disinfectants containing alcohol. The operator manual previously stated to avoid using alcohol-based cleaners on some parts of the ILED, but after reviewing this it was determined that it was not clearly stated to avoid use on the covers.

Device

Device Recall ILED Surgical Light

Manufacturer

Trumpf Medical Systems, Inc.
  • Manufacturer Address
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA