Recall Z-0853-2026— Philips North America Llc

Name: FDA recall Z-0853-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-31

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2025-10-31. It names one FDA 510(k) clearance: K151681. Product: IntelliVue MP40. Product Number: M8003A.. Reason: Potential issue where the IntelliVue monitors did not alarm..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2025-10-31
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K151681 — IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH·cleared 2015-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IntelliVue MP40. Product Number: M8003A.

Reason for recall

Potential issue where the IntelliVue monitors did not alarm.

Data sourced from openFDA. This site is unofficial and independent of the FDA.