BEUDAMED
    FDA Recall Terminated

    Phototherapy Lamp, Model 9001W501JE

    Recall: Z-0241-04 · Initiated December 5, 2003

    Recall

    Recall Number
    Z-0241-04
    Event Number
    27875
    Firm
    Fisher & Paykel Healthcare Inc
    FEI Number
    3000210616
    Product Code
    LBI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2003
    Posted
    December 18, 2003
    Terminated
    November 23, 2005
    Address
    22982 Alcalde Drive, 101, Laguna Hills, CA, 92653

    Description

    Phototherapy Lamp, Model 9001W501JE

    Reason

    Component placement presents risk of electrocution to patients.

    Action

    A recall letter and a set of instructions for fixing the units was sent to customers with instructions to complete a fax back form to indicate completion of the repair.

    Distribution

    Nationwide.

    Quantity

    88