Philips IntelliVue MX40 Patient Monitor Recalled for Battery Notification Issues
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible low-battery alerts, potentially disrupting patient monitoring.
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 risk of harm (loss of monitoring/alarming) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips North America, LLC is recalling IntelliVue MX40 Patient Monitors (Product number 865352) due to a defect in the low-battery state. The affected devices may experience increased power consumption and may fail to provide visual and/or audible notifications when the battery is low. This issue could result in a lack of local monitoring or alarming if the device is connected to an IntelliVue Information Center, which relies on the MX40 for connectivity.
The recall covers all revision B.X versions of the product. The devices were distributed worldwide, including the United States and 71 other countries. The MX40 is used primarily as a traditional telemetry medical device that connects to the IntelliVue Information Center via a wireless network.
Healthcare facilities should contact Philips North America, LLC for instructions on how to address the issue. Users should verify the service number of their devices against the list of affected units: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371.
The recalled product
- Product
- IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information…
- 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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