IntelliVue Patient Monitor MX500 may fail to generate critical alarms
Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.
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: FDA Class II device with a potential failure-to-alarm condition in a critical patient monitoring system. This represents a risk-of-harm to patients where injury has not yet been reported; the source explicitly describes a potential failure without documented illnesses or injuries.
Plain-English summary
Philips is recalling certain IntelliVue Patient Monitor MX500 units (Model 866064) due to a potential failure to generate alarms for "No Device Data" conditions. The device may fail to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board, which results in loss of device data communication.
This failure-to-alarm condition poses a patient safety risk because healthcare personnel may not be immediately notified when the monitor loses critical data transmission from connected ventilators, potentially delaying awareness of device disconnection or communication failures.
Approximately 45 units of the IntelliVue Patient Monitor MX500 were distributed in the United States (Florida, North Carolina, and Oregon) and internationally (Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, and United Kingdom). The device is identified by Model Number 866064.
Healthcare facilities that have received this device should contact Philips North America LLC for instructions regarding remediation or replacement. The FDA encourages healthcare providers to report any actual failures or adverse events related to this device.
The recalled product
- Product
- IntelliVue Patient Monitor MX500. Model Number: 866064
- Manufacturer
- Philips North America Llc
- Affected units
- 45
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 (20)
- Model Number: 866064. UDI-DI: (01)00884838038776(21)
- Serial Numbers: DE7580A1R5
- DE7580A1R4
- DE7580A1R1
- DE7580A1R0
- DE7580A1PM
- DE7580A1PL
- DE7580A1PK
- DE7580A1PJ
- DE7580A1P5
- DE351C8913
- DE351C8912
- DE351C8908
- DE351C8911
- DE351C8910
- DE351C8909
- DE32300881
- DE32300882
- DE32300883
- DE32300937
Distribution
Part of a larger recall action
This product is one of 5 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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