IntelliVue Patient Monitor MX550 May Fail to Alarm on Ventilator Disconnection
Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.
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 risk-of-harm medical device where alarm failure on ventilator disconnection could result in serious patient harm. The recall is classified as FDA Class II with no reported illnesses or injuries to date, qualifying it as a high-risk product with potential for harm but without reported adverse events.
Plain-English summary
Philips North America LLC has recalled 74 units of the IntelliVue Patient Monitor MX550 (Model 866066) due to a potential failure in alarm functionality.
The affected monitors may fail to generate an alarm when a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board, resulting in a "No Device Data" inoperative state. This failure to alarm could prevent clinical staff from being immediately notified of the disconnection, potentially delaying recognition of the event and appropriate patient care.
The recalled units were distributed to facilities in Florida, North Carolina, and Oregon in the United States, as well as internationally to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, and the United Kingdom.
If you operate an affected monitor, contact Philips immediately for instructions on how to address this issue.
The recalled product
- Product
- IntelliVue Patient Monitor MX550. Model Number: 866066
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Patient Monitor
- Affected units
- 74
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: 866066. UDI-DI: (01)00884838038783(21)
- Serial Numbers: DE671E3020
- DE671E2989
- DE671E2988
- DE671E3086
- DE671E3085
- DE671E3084
- DE671E3097
- DE671E3096
- DE671E3095
- DE671E3094
- DE671E3093
- DE671E3253
- DE671E3246
- DE671E3245
- DE671E3244
- DE671E3241
- DE671E3240
- DE671E3234
- DE671E3235
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 · failure to alarm
See all →- HighIntelliVue Patient Monitor MX500 may fail to generate critical alarms
FDA (Devices) · 2025-02-12
- HighOxygen Sensors in Incubators May Display Inaccurate Readings
FDA (Devices) · 2021-08-25
- HighPhilips SureSigns VS3 NBP Recall for Pulse Rate Measurement Limitation
FDA (Devices) · 2019-05-22
- HighPhilips SureSigns VS3 Monitor Recall Due to Software Defect
FDA (Devices) · 2019-05-22
- HighPhilips SureSigns VS3 Monitor Software Defect Recall
FDA (Devices) · 2019-05-22
Similar recalls
- HighIntelliVue MX850 patient monitors recalled over the 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 MX750 patient monitors recalled because the devices may not alarm
FDA (Devices) · 2025-12-10
- HighIntelliVue MX550 patient monitors recalled over an alarm activation issue
FDA (Drugs) · 2025-12-10
- HighIntelliVue MX700 patient monitors recalled over an issue with alarm activation
FDA (Devices) · 2025-12-10
- HighIntelliVue MX600 patient monitors recalled because an alarm may not sound
FDA (Devices) · 2025-12-10