BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1789-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1789-2014
    Event ID
    68226
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Childrens Medical Ventures
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    April 29, 2014
    Classification Date
    June 13, 2014
    Termination Date
    April 6, 2015
    Address
    191 Wyngate Dr, N/A, Monroeville, PA, 15146-3045, United States

    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.

    Code Info

    989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971, 989805604631 / 1030271, 989805605051 / 1038140, 989805605061 / 1038141, 989805608801 / U1014557, 989805608811 / U1014559, 989805608831 / U1028969, 989805608841 / U1028970, 989805608851 / U1038140, 989805604231 / 1023384

    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