BEUDAMED
    FDA Recall Terminated

    Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    Recall: Z-2353-2015 · Initiated July 27, 2015

    Recall

    Recall Number
    Z-2353-2015
    Event Number
    71718
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 27, 2015
    Posted
    August 7, 2015
    Terminated
    May 3, 2017
    Address
    1046 Legrand Blvd, Charleston, SC, 29492-7672

    Description

    Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    Reason

    Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

    Action

    Consignees were notified by letter on/about 7/27/2015.

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*

    Quantity

    9,287 units (total)