BEUDAMED
    FDA Recall Terminated

    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.

    Recall: Z-1789-2014 · Initiated April 29, 2014

    Recall

    Recall Number
    Z-1789-2014
    Event Number
    68226
    Firm
    Childrens Medical Ventures
    FEI Number
    3007056120
    Product Code
    NPF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 29, 2014
    Posted
    June 13, 2014
    Terminated
    April 6, 2015
    Address
    191 Wyngate Dr, Monroeville, PA, 15146-3045

    Description

    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.

    Reason

    The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.

    Action

    Philips sent an Urgent Medical Device Correction letter dated April 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Customer Information is intended to inform you about: 1.what the problem is and under what circumstances it can occur 2.the actions that you as a customer can take to minimize the effect of the problem 3.the actions planned by Philips to correct the problem. If you need any further information or support concerning this issue, please contact your local Philips representative: For further questions please call (412) 380-8881. Philips apologizes for any inconveniences caused by this problem.

    Distribution

    Worldwide Distribution - USA including the states of MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV and VA., and the countries of Australia, Belgium and Canada.

    Quantity

    112