Events

Recall of Uterine Electromyographic Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MONICA HEALTHCARE LTD.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77313
  • Event Risk Class
    Class 2
  • Event Number
    Z-2588-2017
  • Event Initiated Date
    2017-04-28
  • Event Date Posted
    2017-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155680
  • Notes / Alerts
    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.
  • Extra notes in the data
    Uterine electromyographic monitor - Product Code OSP
  • Reason
    Monica novii wireless patch system-potential battery damage and excess heat through prolonged charging.
  • Action
    The recall strategy outlined below addresses the depth of the recall, plan for public notification, and recall notification (customer letter) effectiveness check. This issue will be resolved by sending an Urgent Medical Device Correction customer letter (attached) to customers with affected units. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to correct all affected Products at no cost to the customer. The plan for public notification is to contact all customers with affected systems by means of an Urgent Medical Device Correction via e-mail. This letter will be sent to the following titles within the affected accounts: Nurse Managers, Labor & Delivery/Bio-medical Engineering Department Managers/Risk Management Directors. We will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures

Device

Uterine Electromyographic Monitor
  • Model / Serial
    See attached consignee list for affected device serial numbers.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.
  • Product Description
    Monica Novii Wireless Patch System || product Usage: || Novii Interface - 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. 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. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
  • Manufacturer
    MONICA HEALTHCARE LTD

Manufacturer

MONICA HEALTHCARE LTD
  • Manufacturer Address
    MONICA HEALTHCARE LTD, Interchange 25 Business Park, Bostocks Lane, Nottingham United Kingdom
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA