IntelliVue Patient Monitors recalled for electrical grounding defect
Philips is recalling approximately 545 IntelliVue Patient Monitor units with a broken ground bolt that may cause loss of electrical grounding, potentially affecting the device's electromagnetic immunity and emission.
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: This is an FDA Class II medical device recall involving a potential electrical grounding defect in patient monitors used in critical care settings. The source does not report injuries or adverse events, but the risk-of-harm nature of a patient monitoring device with a confirmed manufacturing defect affecting electrical grounding warrants a High severity classification.
Plain-English summary
Philips North America is recalling approximately 545 IntelliVue Patient Monitor units (models MX400, MX430, MX450, MX500, and MX550). During manufacturing, one device was found with a broken ground bolt on the power supply, which can disconnect the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the device's electromagnetic immunity and emission characteristics.
The affected devices were shipped after April 26, 2024, and have been distributed nationwide in the United States and globally. The recalled monitors are used in hospitals, clinics, and other healthcare facilities for continuous patient monitoring.
Healthcare facilities can identify potentially affected units by checking the manufacturing date on the back of the monitor. Facilities should contact Philips North America for instructions on inspection, repair, or replacement of the affected power supply units.
The recalled product
- Product
- IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
- Manufacturer
- Philips North America
- Category
- Medical Device — Patient Monitor
- Affected units
- 545
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 (15)
- IntelliVue Patient Monitor MX400
- 866060
- UDI-DI: 00884838038752
- IntelliVue Patient Monitor MX430
- 866061
- UDI-DI: 00884838057562
- IntelliVue Patient Monitor MX450
- 866062
- UDI-DI: 00884838038769
- IntelliVue Patient Monitor MX500
- 866064
- UDI-DI: 00884838038776
- IntelliVue Patient Monitor MX550
- 866066
- UDI-DI: 00884838038783
Distribution
Distributed nationwide across the United States.
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