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.
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 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
- Hazard
- failure-to-alarm
- ventilator-disconnection
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
Distribution scope not specified by the agency.
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