The Recall Desk
HighFDA (Devices)·Z-0545-2021·Announced 2020-12-16

Philips IntelliVue MP2 Patient Monitors Recalled for Speaker Failure

Philips is recalling two IntelliVue MP2 patient monitors because speaker failures may prevent audible alarms, potentially delaying patient treatment.

What this means for you

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 is classified as FDA Class II. The hazard involves a risk of harm (delayed treatment) due to a failure of a safety-critical alarm function, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling two units of the IntelliVue MP2 Patient Monitor (model 865040) due to a defect in the speaker system. The recall affects specific serial numbers DE73602213 and DE73602577. These devices are intended for monitoring and recording physiological parameters and generating alarms for adults, pediatrics, and neonates in hospital environments and during patient transport.

The identified hazard is that the speakers on the monitors may fail. This failure is identified by the display of a 'Speaker Malfunct. INOP' message or by the absence of audible sound. If the speaker fails, the monitor may not generate audible alarms, which may result in delayed treatment of the patient.

The affected units were distributed worldwide, including in the United States (specifically South Dakota) and in China, England, Germany, Hong Kong, and Portugal. Healthcare facilities should check their inventory for these specific serial numbers and contact Philips for instructions on repair or replacement.

The recalled product

Product
Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside
Affected units
2

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Philips North America 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 →