BEUDAMED
    FDA Recall Terminated

    Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module

    Recall: Z-0485-2007 · Initiated October 9, 2006

    Recall

    Recall Number
    Z-0485-2007
    Event Number
    37003
    Firm
    Fisher & Paykel Healthcare Ltd 15 Maurice Paykel Place Auckland New Zealand
    FEI Number
    3002806988
    Product Code
    FMT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 9, 2006
    Posted
    January 11, 2007
    Terminated
    April 26, 2012

    Description

    Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module

    Reason

    This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result.

    Action

    Fisher & Paykel Healthcare commenced sending out Product Correction Notifications letter via U.S. Postal Service certified mail October 9, 2006. This Product Correction Notice explained the nature of the problem and include a reminder of the maximum recommended weight of accessories. Two FAX Response Forms were provided, Part A for initial receipt of the Product Correction Notice and Part B for confirmation of the completed upgrade.

    Distribution

    Nationwide and Canada

    Quantity

    273 units in US & 9 in Canada