# FDA recall Z-1292-2018

> **GE Healthcare, LLC** · Class II · device recall initiated 2017-12-15.

## Product

Uterine Electromyographic Monitor - Monica Novii Wireless Patch System    Product Usage:  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 via three cables. 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.

## Reason for recall

if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).

## Distribution

Worldwide - US Nationwide Distribution.

## Key facts

- **Recall number:** Z-1292-2018
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-15
- **Report date:** 2018-04-11
- **Termination date:** 2020-04-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1292-2018

## Citation

> AI Analytics. FDA recall Z-1292-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1292-2018. Source: US FDA. Licensed CC0.

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