Agency classClass IIOur severity:High FDA (Devices)·Z-1692-2019·Announced 2019-06-12

Philips IntelliVue MX40 Patient Monitor Recalled for Battery Defect

Philips is recalling IntelliVue MX40 Patient Monitors because they may experience increased power consumption and lack visual or audible notifications when in a low battery state.

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 medical device with a risk of harm (lack of notifications) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Philips North America, LLC is recalling the IntelliVue MX40 Patient Monitor, Product number 865350. The affected devices are used primarily as traditional telemetry medical devices that connect to the IntelliVue Information Center via a wireless network. When connected to the Information Center, the center provides the primary patient monitoring and alarming function, and the MX40 does not automatically provide local monitoring or alarming.

The recall is due to a defect where the MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State. All revision B.X versions of the product are affected. The devices were distributed worldwide, including nationwide in the US and to 71 countries.

Healthcare facilities should contact Philips North America, LLC for instructions on how to address the issue with the affected patient monitors.

The recalled product

Product: IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is…
Manufacturer: Philips North America, LLC
Category: Medical Device — Patient Monitor
Hazard: battery-defect
lack-of-notification

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 defect