MONICA HEALTHCARE LTD: 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.

Recall number

Z-2588-2017

Recalling firm

MONICA HEALTHCARE LTD

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.

Status

Terminated

Initiated

2017-04-28

Posted

2017-05-25

Terminated

2018-03-01

Reason

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

Root 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

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.

Lot, serial or model codes

See attached consignee list for affected device serial numbers.

510(k) numbers

["K140862"]

PMA numbers

not on file

Product code

OSP

Firm FEI

3012527466

Firm city

Nottingham

Firm state

not on file

Firm country

United Kingdom

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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