Events

Rappel de Device Recall Monica IF24 Interface System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79464
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1293-2018
  • Date de mise en oeuvre de l'événement
    2017-12-15
  • Date de publication de l'événement
    2018-03-14
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162389
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Uterine electromyographic monitor - Product Code OSP
  • Cause
    If the cables of the monica if24 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

Device

Device Recall Monica IF24 Interface System
  • Modèle / numéro de série
    Model # - 105-PT-001 ( all units distributed from October 2011 - May 2016)
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide - US Nationwide Distribution.
  • Description du dispositif
    Uterine Electromyographic Monitor -Monica IF24 Interface System || Product Usage: || The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA