Patient Monitor May Fail to Alert When Ventilator Disconnects
Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.
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 a Class II FDA recall of a high-risk medical device (patient monitor) where the potential hazard—failure to alarm during a critical disconnection event—could lead to patient harm. No injuries or illnesses have been reported, and the defect is described as a potential failure rather than confirmed malfunction. Per the rubric, risk-of-harm products with no reported injury warrant a score of 3.
Plain-English summary
Philips North America LLC is recalling certain IntelliVue Patient Monitor MX450 units (Model Number 866062). The affected devices may fail to generate an alarm notification when a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
This failure to alarm could delay clinical staff from recognizing that a ventilator has been disconnected from the patient, which represents a potential patient safety risk in hospital and critical care settings.
A total of 98 units were distributed in the United States (Florida, North Carolina, and Oregon) and internationally (Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, and United Kingdom). Healthcare facilities using affected units should verify their device model and serial numbers against the recall notice and contact Philips for further guidance.
The recalled product
- Product
- IntelliVue Patient Monitor MX450. Model Number: 866062
- Manufacturer
- Philips North America Llc
- Affected units
- 98
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: 866062. UDI-DI: (01)00884838038769(21)
- Serial Numbers: DE35169761
- DE671V3903
- DE671V3885
- DE671V7898
- DE7770DC1L. UDI-DI: 884838045859
- Serial Numbers: DE32303399
- DE32302479
- DE32302480
- DE32306956
- DE35131294
- DE35114613
- DE35114612
- DE671T9641
- DE7770C86L
- DE7770C86K
- DE7770C86J
- DE7770C86H
- DE7770C86G
- DE35120431
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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