MONICA HEALTHCARE LTD recalls Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Po…

Recall date

April 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2588-2017

FDA classification

Class II

Brand / firm

MONICA HEALTHCARE LTD

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.