Uterine Electromyographic Monitor - Monica Novii Wireless… recallZ-1292-2018 · GE Healthcare, LLC · initiated Dec 15, 2017
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Device Design
What the company is doing
GE Healthcare sent an Urgent Medical Device correction Letter dated December 15, 2017 to their customers. The letter identified the affected product, problem and action to be taken. Customers are instructed to: 1. Follow the attached safety instructions to replace the screws, see attached page 2. 2. Follow the attached safety instructions to perform the Monica Novii function TEST to confirm correct cable connection, see attached page 3. 3. If the Monica Novii System fails the Novii function TEST, contact a GE Healthcare Representative to schedule repair/replacement. 4. If the Monica Novii System passes the Novii function TEST, you may continue to use Monica Novii System without any further action. 5. Complete the attached fax back form (page 4&5) for all Monica Novii System as soon as you have completed the screw replacement. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative
Recall details
- Recall number
- Z-1292-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 15, 2017
- Posted by the FDA
- Mar 14, 2018
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 1742
- Product code
- OSP
- FDA submissions
- K140862
- Distribution
- Worldwide - US Nationwide Distribution.
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.
Code information (models, lots, serial numbers)
Model # - 107-PT-020 ( all units distributed from January 2016- November 2017)
Other devices under the same FDA submission
1 device cleared under K140862 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Novii Interface 107-PT-001Datex-Ohmeda, Inc. · Uterine electromyographic monitor1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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