Agency classClass IIOur severity:High FDA (Devices)·Z-1292-2018·Announced 2018-04-11

GE Healthcare Recalls Monica Novii Wireless Patch System Due to Signal Swap Risk

GE Healthcare is recalling 1,742 units of the Monica Novii Wireless Patch System because incorrectly reconnected cables may cause fetal and maternal heart rate signals to be displayed swapped.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a user error could lead to incorrect display of vital signs (swapped fetal and maternal heart rates), representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 1,742 units of the Uterine Electromyographic Monitor - Monica Novii Wireless Patch System. The recall involves Model # 107-PT-020 units distributed from January 2016 through November 2017. These products were distributed worldwide and nationwide in the United States.

The recall was initiated because 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, appearing swapped on the monitor. The Novii Interface is an accessory that provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables.

Healthcare facilities and users who have this product should stop using it and contact GE Healthcare for further instructions on the recall.

The recalled product

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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Fetal Monitoring
Hazard: mis-labeling
incorrect-display
Affected units: 1,742

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · GE Healthcare, LLC

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