Patient Monitor May Fail to Alarm on Ventilator Disconnect
Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.
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: This is an FDA Class II medical device with a potential failure to alarm—a risk-of-harm scenario for patient monitoring. No injuries or illnesses have been reported, placing it at the 'High' severity level per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Philips North America LLC is recalling 28 IntelliVue Patient Monitor MX400 units (Model 866060) due to a potential failure to generate an alarm when a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
The affected units were distributed in the United States to Florida, North Carolina, and Oregon, and internationally to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, and the United Kingdom.
The recalled product
- Product
- IntelliVue Patient Monitor MX400. Model Number: 866060
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
- Hazard
- alarm-failure
- ventilator-disconnect
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)
- DE35174084
- DE35174083
- DE35174082
- DE35174080
- DE35107369
- DE35108320
- DE35160410
- DE671M4116
- DE7770DA9W
- DE35114616
- DE35114618
- DE671E8921
- DE671E8917
- DE7580AH50
- DE7580AHEH
- DE35123130
- DE671V9297
- DE671V9296
- DE671V9298
- DE35160989
Distribution
Distribution scope not specified by the agency.
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