# FDA recall Z-0020-2025

> **Philips North America Llc** · Class II · device recall initiated 2023-06-14.

## Product

IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:    1)	IntelliVue MX400 	866060;  2)	IntelliVue MX450	      866062;  3)	IntelliVue MX500	      866064;  4)	IntelliVue MX550	      866066     Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

## Reason for recall

Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these  devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.

## Distribution

Foreign Only:  Denmark France Germany Japan United Kingdom

## Key facts

- **Recall number:** Z-0020-2025
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-14
- **Report date:** 2024-10-16

- **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-0020-2025

## Citation

> AI Analytics. FDA recall Z-0020-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0020-2025. Source: US FDA. Licensed CC0.

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