BEUDAMED
    FDA Recall Terminated

    UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039

    Recall: Z-1821-2017 · Initiated March 22, 2017

    Recall

    Recall Number
    Z-1821-2017
    Event Number
    76810
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 22, 2017
    Terminated
    May 17, 2021
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039

    Reason

    Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.

    Action

    Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips.

    Distribution

    Nationwide, worldwide including Canada

    Quantity

    6992 (total for all devices)