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.
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 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
- Affected units
- 28
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
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.
See all 5 products in this recall →Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · alarm failure
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighTreatlife smoke and carbon monoxide detectors can fail to alarm
CPSC · 2026-06-25
- SevereAutomated Impella Controllers recalled over alarm, power and purge cassette faults
FDA (Devices) · 2026-06-03
- HighVital Sync remote monitoring may not receive bedside monitor alarms
FDA (Devices) · 2026-03-18
- HighSmoke alarms recalled because they may not sound in time
CPSC · 2026-02-12
Similar recalls
- HighIntelliVue MX400 patient monitors recalled over a potential failure to alarm
FDA (Devices) · 2025-12-10
- HighIntelliVue MX500 patient monitors recalled over a potential failure to alarm
FDA (Devices) · 2025-12-10
- HighIntelliVue MX850 patient monitors recalled over the potential failure to alarm
FDA (Devices) · 2025-12-10
- HighIntelliVue MX800 patient monitors recalled because the devices may not alarm
FDA (Devices) · 2025-12-10
- HighIntelliVue MX600 patient monitors recalled because an alarm may not sound
FDA (Devices) · 2025-12-10
- HighIntelliVue MX700 patient monitors recalled over an issue with alarm activation
FDA (Devices) · 2025-12-10