BEUDAMED
    FDA Enforcement Class II Terminated

    Fetal Spiral Electrode, Model No. 9898 031 37631

    Recall: Z-1250-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1250-2019
    Event ID
    82422
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2019
    Initiation Date
    January 25, 2019
    Classification Date
    May 2, 2019
    Termination Date
    December 8, 2020
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Fetal Spiral Electrode, Model No. 9898 031 37631

    Reason

    During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.

    Code Info

    All products currently in distribution.

    Distribution

    Distributed nationwide within US. Worldwide international distribution.

    Quantity

    1,971,925 (78,877 boxes)