BEUDAMED
    FDA Recall Terminated

    Drager PT 4000 Phototherapy System

    Recall: Z-1950-2012 · Initiated July 2, 2012

    Recall

    Recall Number
    Z-1950-2012
    Event Number
    62470
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    2510954
    Product Code
    LBI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 2, 2012
    Posted
    July 6, 2012
    Terminated
    July 1, 2013
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Drager PT 4000 Phototherapy System

    Reason

    A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b

    Action

    Drager Medical Systems sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 2012 to all affected customers. The letter identifies the product, problem, and actions to bee taken by the customers. In addition, a Customer Reply Card was included for customers to complete and return. Contact the firm at 800-543-5047 for questions regarding this recall.

    Distribution

    Nationwide Distribution-USA (nationwide) and Puerto Rico.

    Quantity

    65