IntelliVue Multi Measurement Server X2. Product Number:… recallZ-0859-2026 · Philips North America Llc · initiated Oct 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential issue where the IntelliVue monitors did not alarm.
FDA root cause category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-0859-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 31, 2025
- Posted by the FDA
- Dec 2, 2025
- Recalling firm
- Philips North America Llc
- Quantity
- 1,913,441 units
- Product code
- DSI
- FDA submissions
- K150310
- 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 description
IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Code information (models, lots, serial numbers)
Product Number: M3002A; UDI-DI: 00884838000261; All Serial No.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IntelliVue Multi Measurement Server X2 865039Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall7 deaths506 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97917).
- Z-0849-2026 · Open, ClassifiedIntelliVue MP2. Product Number: M8102A.
- Z-0850-2026 · Open, ClassifiedIntelliVue MP5. Product Number: M8105A.
- Z-0860-2026 · Open, ClassifiedIntelliVue Multi-Measurement Module X3. Product Number: 867030.
- Z-0861-2026 · Open, ClassifiedIntelliVue Patient Monitor MX100. Product Number: 867033.
- Z-0862-2026 · Open, ClassifiedIntelliVue Patient Monitor MX400. Product Number: 866060.
- Z-0863-2026 · Open, ClassifiedIntelliVue Patient Monitor MX450. Product Number: 866062.
- Z-0864-2026 · Open, ClassifiedIntelliVue Patient Monitor MX500. Product Number: 866064.
- Z-0865-2026 · Open, ClassifiedIntelliVue Patient Monitor MX550. Product Number: 866066.
- Z-0866-2026 · Open, ClassifiedIntelliVue Patient Monitor MX600. Product Number: 865242.
- Z-0867-2026 · Open, ClassifiedIntelliVue Patient Monitor MX700. Product Number: 865241.
- Z-0868-2026 · Open, ClassifiedIntelliVue Patient Monitor MX750. Product Number: 866471.
- Z-0869-2026 · Open, ClassifiedIntelliVue Patient Monitor MX800. Product Number: 865240.
- Z-0870-2026 · Open, ClassifiedIntelliVue Patient Monitor MX850. Product Number: 866470.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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