MONICA HEALTHCARE LTD: Medical Device Recall in 2017 - (Recall #: Z-2588-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 28, 2017

Date Posted: June 21, 2017

Recall Number: Z-2588-2017

Event ID: 77313

Reason for Recall:

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

Status: Terminated

Product Quantity: 4,110 (4,106 US; 4 OUS)

Code Information:

See attached consignee list for affected device serial numbers.

Distribution Pattern:

The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.

Voluntary or Mandated:

Voluntary: Firm initiated