Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Defects
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible alerts when the battery is low.
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 involves a medical device where the failure to provide low battery notifications poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America, LLC is recalling the IntelliVue MX40 Patient Monitor, Product number 857146, with Service Numbers 453564711531 and 453564711541. The affected devices are used primarily as traditional telemetry medical devices and connect to the IntelliVue Information Center via a wireless network. When connected to the Information Center, the central system provides the primary patient monitoring and alarming function, meaning 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 fail to provide visual and/or audible notifications while in a Low Battery State. This issue affects all revision B.X versions of the device. The products were distributed worldwide, including nationwide in the United States and to 71 other countries.
Healthcare facilities should contact Philips North America, LLC for instructions on how to address the issue. The source text does not specify a specific action for consumers, as the product is a professional medical device.
The recalled product
- Product
- IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - 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 c
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
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.
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