IntelliVue MP2 (Philips) – Alarm Failure Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IntelliVue MP2. Product Number: M8102A.
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Product Number: M8102A, UDI-DI: 00884838000278, All Serial No.
Products Sold
Product Number: M8102A; UDI-DI: 00884838000278; All Serial No.
Philips North America Llc is recalling IntelliVue MP2. Product Number: M8102A. due to Potential issue where the IntelliVue monitors did not alarm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential issue where the IntelliVue monitors did not alarm.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026