Monica Novii Wireless Patch System product Usage: Novii Interface — Class II medical device recall Z-2588-2017
Terminated recall by MONICA HEALTHCARE LTD, reported 2017-06-21. Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
| Recall number | Z-2588-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MONICA HEALTHCARE LTD, Nottingham, N/A, United Kingdom |
| Recall initiated | 2017-04-28 |
| Classified | 2017-06-14 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-03-01 |
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.
Reason for recall
Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.