FDA DeviceClass IINotable

FDA Recall: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Date: 2026-07-01
Brand: Philips North America Llc
Category: Medical Device
FDA Class: Class II

Description

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Hazard

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Remedy

285 units

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