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Monica Novii Wireless Patch System recallZ-2588-2017 · Monica Healthcare Ltd · initiated Apr 28, 2017

Class II Terminated All recalls posted in May 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Monica Healthcare Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-2588-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 28, 2017
Posted by the FDA
May 25, 2017
Recalling firm
Monica Healthcare Ltd
Quantity
4,110 (4,106 US; 4 OUS)
Product code
OSP
FDA submissions
K140862
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.

Code information (models, lots, serial numbers)

See attached consignee list for affected device serial numbers.

Other devices under the same FDA submission

1 device cleared under K140862 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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