BEUDAMED
    FDA Enforcement Class II Terminated

    Drager PT 4000 Phototherapy System

    Recall: Z-1950-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1950-2012
    Event ID
    62470
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2012
    Initiation Date
    July 2, 2012
    Classification Date
    July 6, 2012
    Termination Date
    July 1, 2013
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    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

    Code Info

    Catalog number 2M21700 and serial numbers ASCF-0037 TO ASCF-0061; ASCJ-0037 TO ASCJ-0152; ASCL-0001 TO ASCL-0025; ASCM-0001 TO ASCM-0025; and ASDA-002, 0005, 0006, 0007, 0008, 0009, 0012, 0019, 0025.

    Distribution

    Nationwide Distribution-USA (nationwide) and Puerto Rico.

    Quantity

    65