Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Recalled by GE Healthcare, LLC Due to if the cables of the Monica Novii System...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.
Affected Products
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.
Quantity: 1742
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE Healthcare, LLC
GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report