# FDA recall Z-1108-2025

> **Philips North America Llc** · Class II · device recall initiated 2025-01-15.

## Product

IntelliVue Patient Monitor MX450. Model Number: 866062

## 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.

## Distribution

US distribution to Florida, North Carolina, and Oregan.  International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-1108-2025
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-15
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2025

## Citation

> AI Analytics. FDA recall Z-1108-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1108-2025. Source: US FDA. Licensed CC0.

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