Class 2 Device Recall Uterine Electromyographic Monitor

• Date Initiated by Firm: April 28, 2017
• Date Posted: May 25, 2017
• Recall Status: Terminated on March 01, 2018
• Recall Number: Z-2588-2017
• Recall Event ID: 77313
• 510(K)Number: K140862
• Product Classification: Uterine electromyographic monitor - Product Code OSP
• Product: 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.
• Code Information: See attached consignee list for affected device serial numbers.
• Recalling Firm/ Manufacturer: MONICA HEALTHCARE LTD; Interchange 25 Business Park; Bostocks Lane; Nottingham United Kingdom
• Manufacturer Reason for Recall: Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
• FDA Determined Cause: Nonconforming Material/Component
• 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
• Quantity in Commerce: 4,110 (4,106 US; 4 OUS)
• Distribution: The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OSP and Original Applicant = MONICA HEALTHCARE LTD.