Agency classClass IIOur severity:High FDA (Devices)·Z-1293-2018·Announced 2018-04-11

GE Healthcare Recalls Monica IF24 Interface System Due to Signal Swap Risk

GE Healthcare is recalling 355 Monica IF24 Interface Systems because incorrectly reconnected cables can cause fetal and maternal heart rate signals to be displayed incorrectly.

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 risk-of-harm product where incorrect signal display could lead to clinical misinterpretation, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 355 units of the Monica IF24 Interface System, a medical device accessory used to connect the Monica AN24 to a CTG Fetal Monitor. The recall covers Model # 105-PT-001 units distributed worldwide and in the US from October 2011 to May 2016.

The recall was initiated because if the cables of the Monica IF24 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). This device is intended for use by healthcare professionals in a clinical setting.

Healthcare professionals should stop using the affected devices and contact GE Healthcare for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product: Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Fetal Monitoring
Hazard: mis-labeling
signal-swap
Affected units: 355

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 # - 105-PT-001 ( all units distributed from October 2011 - May 2016)

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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