# FDA recall Z-0865-2026

> **Philips North America Llc** · Class II · device recall initiated 2025-10-31.

## Product

IntelliVue Patient Monitor MX550. Product Number: 866066.

## Reason for recall

Potential issue where the IntelliVue monitors did not alarm.

## Distribution

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Botswana, Brazil, Brunei, Bulgaria, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Equat Guinea, Estonia, Ethiopia, Faroe Islands, Finland, French Polynesia, France, French Guiana, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea Rep, Kuwait, Lao, Latvia, Lebanon, Lesotho, Liberia, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Nam

## Key facts

- **Recall number:** Z-0865-2026
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-31
- **Report date:** 2025-12-10

- **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-0865-2026

## Citation

> AI Analytics. FDA recall Z-0865-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0865-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*