IntelliVue MP60. Product Number: M8005A.

FDA device recall Z-0855-2026 · posted 2025-12-02 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

Potential issue where the IntelliVue monitors did not alarm.

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.

Root cause

Use error

Status

Open, Classified

Product code

DSI

Quantity affected

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, Bos

Date initiated

2025-10-31

Date posted

2025-12-02

Location

Cambridge, MA

Related 510(k) clearances