Recall record at a glance
| Official record | Z-2588-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | MONICA HEALTHCARE LTD |
| Report date | Jun 21, 2017 |
| Recall initiation date | Apr 28, 2017 |
| Quantity | 4,110 (4,106 US; 4 OUS) |
| Location | Nottingham, N/A, United Kingdom |
Official 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.
Why the product was recalled
Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
Distribution information
The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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