BEUDAMED
    FDA Recall Terminated

    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094

    Recall: Z-1927-2018 · Initiated November 16, 2017

    Recall

    Recall Number
    Z-1927-2018
    Event Number
    79340
    Firm
    GETINGE US SALES LLC
    FEI Number
    3012092534
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    November 16, 2017
    Posted
    March 5, 2018
    Terminated
    July 21, 2021
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094

    Reason

    Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.

    Action

    Maquet/Getinge notified customers via an Urgent Medical Device Recall Notice dated November 16, 2017.

    Distribution

    U.S. and Gov. accts.

    Quantity

    667