Agency classClass IIOur severity:High FDA (Devices)·Z-1693-2019·Announced 2019-06-12

Philips IntelliVue MX40 Patient Monitor Recalled for Battery Issues

Philips is recalling IntelliVue MX40 Patient Monitors because they may consume excess power and fail to provide visual or audible low-battery alerts.

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, and the hazard involves a medical device failing to provide critical low-battery alerts, which poses a risk of harm to patients even if specific injuries have not yet been reported.

Plain-English summary

Philips North America, LLC is recalling IntelliVue MX40 Patient Monitors (Product number 865351) due to a defect in the battery management system. The affected devices may experience increased power consumption and may fail to provide visual and/or audible notifications when the battery reaches a low state.

The recall covers all revision B.X versions of the device, which are distributed worldwide, including the United States and 71 other countries. The MX40 is primarily used as a traditional telemetry medical device that connects to the IntelliVue Information Center via a wireless network. When connected to the Information Center, that system provides the primary patient monitoring and alarming function, while the MX40 does not automatically provide local monitoring or alarming.

Healthcare facilities should contact Philips for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product…
Manufacturer: Philips North America, LLC
Category: Medical Device — Patient Monitor
Hazard: battery-failure
lack-of-alerts

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)

All revision B.X versions are affected.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Philips North America, LLC

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Same hazard · battery failure