Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Monica Novii Wireless Patch System product Usage: Novii Interface - Recalled by MONICA HEALTHCARE LTD Due to Monica Novii Wireless Patch System-Potential battery damage and...

Date: April 28, 2017
Company: MONICA HEALTHCARE LTD
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MONICA HEALTHCARE LTD directly.

Affected Products

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.

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

Why Was This Recalled?

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

Where Was This Sold?

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

About MONICA HEALTHCARE LTD

MONICA HEALTHCARE LTD has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report