Z-0862-2026Class II
IntelliVue Patient Monitor MX400. Product Number: 866060
Philips North America LLC / initiated 2025-10-31 / Open, Classified
Philips North America Llc began a recall of IntelliVue Patient Monitor MX400. Product Number: 866060 on . FDA classified it as Class II and gives the reason as "Potential issue where the IntelliVue monitors did not alarm". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0862-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- IntelliVue Patient Monitor MX400. Product Number: 866060.
- Product code
- DSI Detector And Alarm, Arrhythmia
- Reason for recall
- Potential issue where the IntelliVue monitors did not alarm.
- FDA root cause
- Use error
- Action
- An URGENT Medical Device Correction notice, dated 10/31/25, was mailed to customers and distributors. Distributors were notified of this correction and instructed to forward the provided recall notification to all consignees. Additionally, distributors are asked to include their contact information for consignees in the provided response form and perform a good faith effort for each customer to obtain a completed response form. Consignees are instructed to notify all users of this recall notification and forward the notice to all who need to be aware within their organization or where affected devices were potentially transferred. Consignees are to re-evaluate and reconfigure device configuration per the provided instructions. Once recall actions have been completed, consignees are to complete the provided response form either via QR code, by email to [email protected], or by fax to 877-499-7223. Philips is planning to develop a software update which will enforce the additional confirmation step when the user enables infinite Alarms Off for IntelliVue MP5 models only. Consignees with any questions can contact Philips at 800-722-9377.
- Quantity in commerce
- 1,913,441 units
- 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, Namibia, Nepal, Netherlands, Netherlands Ant, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, , R¿union, Romania, Russia, Saint Vincent, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, St. Pierre Mqln, Suriname, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Tajikistan, Thailand, Trinidad Tobago, Tunisia, T¿rkiye, Turkmenistan, Uganda, Ukraine, United Kingdom, United States, Uruguay, Utd Arab Emir, Uzbekistan, Venezuela, Viet Nam, Virgin Isl (Br), Virgin Isl (US), White Russia, Yemen, Zambia, Zimbabwe.
- Product codes and lots
- Product Number: 866060; UDI-DI: 00884838038752; All Serial No.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0849-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0850-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0851-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0852-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0853-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0854-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0855-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0856-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0857-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0858-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0859-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0860-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0861-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0862-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0863-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0864-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0865-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0866-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0867-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0868-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0869-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0870-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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