Philips North America Llc recalls IntelliVue Patient Monitor MX500. Model Number: 866064
- Recall date
- January 15, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1109-2025
- FDA classification
- Class II
- Brand / firm
- Philips North America Llc
- Sold / distributed
- US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
IntelliVue Patient Monitor MX500. Model Number: 866064
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