BEUDAMED
    FDA Recall Terminated

    Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.

    Recall: Z-1292-2018 · Initiated December 15, 2017

    Recall

    Recall Number
    Z-1292-2018
    Event Number
    79464
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    OSP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 15, 2017
    Posted
    March 14, 2018
    Terminated
    April 21, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.

    Reason

    if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).

    Action

    GE Healthcare sent an Urgent Medical Device correction Letter dated December 15, 2017 to their customers. The letter identified the affected product, problem and action to be taken. Customers are instructed to: 1. Follow the attached safety instructions to replace the screws, see attached page 2. 2. Follow the attached safety instructions to perform the Monica Novii function TEST to confirm correct cable connection, see attached page 3. 3. If the Monica Novii System fails the Novii function TEST, contact a GE Healthcare Representative to schedule repair/replacement. 4. If the Monica Novii System passes the Novii function TEST, you may continue to use Monica Novii System without any further action. 5. Complete the attached fax back form (page 4&5) for all Monica Novii System as soon as you have completed the screw replacement. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative

    Distribution

    Worldwide - US Nationwide Distribution.

    Quantity

    1742