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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77313

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 28, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MONICA HEALTHCARE LTD

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2588-2017
Recall number
Z-2588-2017
Initiated
April 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
MONICA HEALTHCARE LTD
Quantity
4,110 (4,106 US; 4 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

See attached consignee list for affected device serial numbers.

Distribution pattern

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