IntelliVue MX800 patient monitors recalled because the devices may not alarm
Philips North America is recalling the IntelliVue Patient Monitor MX800 over a potential issue where the monitors did not alarm.
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: Scored 3 under the risk-of-harm criterion: a monitor that fails to alarm can leave a patient event unannounced, and no injuries are reported.
Plain-English summary
The Philips IntelliVue Patient Monitor MX800, product number 865240, is being recalled. The device carries UDI-DI 00884838020733 and the action covers all serial numbers.
The recall follows a potential issue where the IntelliVue monitors did not alarm.
The record lists a quantity of 1,913,441 units for the action. Distribution was worldwide, including nationwide in the United States and to a large number of other countries. The FDA has classified the action as Class II.
A patient monitor that does not alarm may leave a change in a patient's condition unannounced to staff. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- IntelliVue Patient Monitor MX800. Product Number: 865240.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Patient monitor
- Hazard
- alarm-failure
- patient-monitoring
- delayed-response
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 (3)
- Product Number: 865240
- UDI-DI: 00884838020733
- All Serial No.
Distribution
Distributed nationwide across the United States.
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