Recall Z-0860-2026
Philips North America Llc · initiated October 31, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Codes / lots: Product Number: 867030; UDI-DI: 00884838082588; All Serial No.
Reason for recall
Potential issue where the IntelliVue monitors did not alarm.
FDA-determined cause: Use error
Action taken
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 Recall.Response@philips.com, 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.
Details
- Recall number
- Z-0860-2026
- Initiated
- October 31, 2025
- Posted by FDA
- December 2, 2025
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Quantity
- 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…
- Recalling firm
- Philips North America Llc, Cambridge, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0849-2026 Class II | IntelliVue MP2. Product Number: M8102A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0850-2026 Class II | IntelliVue MP5. Product Number: M8105A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0851-2026 Class II | IntelliVue MP20. Product Number: M8001A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0852-2026 Class II | IntelliVue MP30. Product Number: M8002A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0853-2026 Class II | IntelliVue MP40. Product Number: M8003A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0854-2026 Class II | IntelliVue MP50. Product Number: M8004A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0855-2026 Class II | IntelliVue MP60. Product Number: M8005A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0856-2026 Class II | IntelliVue MP70. Product Number: M8007A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0857-2026 Class II | IntelliVue MP80. Product Number: M8008A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0858-2026 Class II | IntelliVue MP90. Product Number: M8010A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0859-2026 Class II | IntelliVue Multi Measurement Server X2. Product Number: M3002A.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0861-2026 Class II | IntelliVue Patient Monitor MX100. Product Number: 867033.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0862-2026 Class II | IntelliVue Patient Monitor MX400. Product Number: 866060.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0863-2026 Class II | IntelliVue Patient Monitor MX450. Product Number: 866062.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0864-2026 Class II | IntelliVue Patient Monitor MX500. Product Number: 866064.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0865-2026 Class II | IntelliVue Patient Monitor MX550. Product Number: 866066.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0866-2026 Class II | IntelliVue Patient Monitor MX600. Product Number: 865242.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0867-2026 Class II | IntelliVue Patient Monitor MX700. Product Number: 865241.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0868-2026 Class II | IntelliVue Patient Monitor MX750. Product Number: 866471.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0869-2026 Class II | IntelliVue Patient Monitor MX800. Product Number: 865240.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |
| Z-0870-2026 Class II | IntelliVue Patient Monitor MX850. Product Number: 866470.Potential issue where the IntelliVue monitors did not alarm. | 10/31/2025Open, Classified |