GE Healthcare, LLC: Medical Device Recall in 2018 - (Recall #: Z-1292-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 15, 2017

Date Posted: April 11, 2018

Recall Number: Z-1292-2018

Event ID: 79464

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).

Status: Terminated

Product Quantity: 1742

Code Information:

Model # - 107-PT-020 ( all units distributed from January 2016- November 2017)

Distribution Pattern:

Worldwide - US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated