Agency classClass IIOur severity:High FDA (Devices)·Z-0544-2021·Announced 2020-12-16

Philips IntelliVue X2 Multi Measurement Server Speaker Failure Recall

Philips is recalling 16 IntelliVue X2 Multi Measurement Servers because speaker failures may prevent audible alarms, potentially delaying patient treatment.

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 is classified as FDA Class II. The hazard involves a risk of harm (delayed treatment) due to a functional failure in a medical device, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Philips North America LLC is recalling 16 units of the IntelliVue X2 Multi Measurement Server (M3002A, model 865039). The recall involves 2 units in the United States and 14 units outside the US. The 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 recall is due to a defect where speakers on the IntelliVue X2 and IntelliVue MP2 systems may fail. This failure is identified by the display of a 'Speaker Malfunct. INOP' message or by the absence of audible sound. The primary risk associated with this defect is the potential for delayed treatment of patients due to the lack of audible alarms.

Affected units are distributed in the US (specifically South Dakota) and in China, England, Germany, Hong Kong, and Portugal. Specific serial numbers for the affected units are listed in the official recall documentation. Healthcare facilities should verify their inventory against the provided serial numbers and contact Philips for further instructions on remediation.

The recalled product

Product: Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - 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…
Manufacturer: Philips North America Llc
Category: Medical Device — Patient Monitoring
Hazard: delayed-treatment
device-failure

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 →

Same manufacturer · Philips North America Llc

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