Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 21, 2017
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-invasi
Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Monica Healthcare LTD recalled Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interfa… - a moderate-severity action.
Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interfa… was recalled by Monica Healthcare LTD in June 21, 2017. Reason: Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.. Check the official notice for the remedy. Verify recall #Z-2588-2017 with the FDA Devices before acting.
The recall
Monica Healthcare LTD issued this moderate-severity FDA Devices recall-Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging..
- Moderate
- severity level
- Class II
- classification
- June 21, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2588-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2588-2017) was formally reported on June 21, 2017, with the manufacturer initiating the action on April 28, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Monica Healthcare LTD is listed as the recalling firm, operating out of Nottingham, N/A. Federal records list the affected scope as 4,110 (4,106 US; 4 OUS).
The documented reason for this recall is: Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging. Distribution data in the federal record shows the product reached: The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4,110 (4,106 US; 4 OUS)
Related Recalls
6
3 from same agency
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.
Reason for recall
Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2588-2017 |
| Date reported | June 21, 2017 |
| Date initiated | April 28, 2017 |
| Recalling firm | Monica Healthcare LTD |
| Firm location | Nottingham, N/A |
| Affected scope | 4,110 (4,106 US; 4 OUS) |
| Distribution | The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2588-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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.. Recalled by Monica Healthcare LTD. Units affected: 4,110 (4,106 US; 4 OUS).
Why was this product recalled? ▼
Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2588-2017.
Where was the recalled product distributed? ▼
Distribution: The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2588-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 21, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.