BEUDAMED
    FDA Recall Terminated

    Fetal Spiral Electrode, Model No. 9898 031 37631

    Recall: Z-1250-2019 · Initiated January 25, 2019

    Recall

    Recall Number
    Z-1250-2019
    Event Number
    82422
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    HGP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 25, 2019
    Terminated
    December 8, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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.

    Action

    On January 25, 2019, the firm distributed Customer Information Medical Device Correction letters to affected customers. The letter informed customers that there was an increase in complaints regarding the Fetal Spiral Electrode tip breaking off, preventing easy removal from the scalp of the newborn infant. Customers were advised to do the following: * Visually examine the FSE upon removal from the newborn scalp to verify the tip is intact. If it is not intact, appropriate measures to locate and remove the missing part should be taken. * Upon receipt of this notice, clinicians should review the following information from the device's Instructions for Use: - Do not pull the Spiral Tip from the fetal skin. Do not pull the FSE wires apart. - Do not over-rotate Spiral Tip during attachment. - Inspect the Spiral Tip to ensure that it is still attached to the FSE Hub. If the tip has separated from the hub and remains embedded in the presenting part, remove it using aseptic technique. Customers were provided with a reply form and asked to complete the form and return it to Philips: 1-877-499-7223 (eFax) or email to [email protected]. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377, option 2.

    Distribution

    Distributed nationwide within US. Worldwide international distribution.

    Quantity

    1,971,925 (78,877 boxes)