IntelliVue Patient Monitor MX500. Model Number: 866064
Reported: February 12, 2025 Initiated: January 15, 2025 #Z-1109-2025
Product Description
IntelliVue Patient Monitor MX500. Model Number: 866064
Reason for Recall
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 45 units
- Distribution
- US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
IntelliVue Patient Monitor MX500. Model Number: 866064. Recalled by Philips North America Llc. Units affected: 45 units.
Why was this product recalled? ▼
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2025. Severity: Moderate. Recall number: Z-1109-2025.
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