Recall Z-1156-2026— Philips North America

Name: FDA recall Z-1156-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-22

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2025-12-22. It names one FDA 510(k) clearance: K153702. Product: Patient Information Center iX; Software Version Number: 4.5.0. Reason: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2025-12-22
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K153702 — M3290B Philips IntelliVue Information Center iXPhilips Medical Systems·cleared 2016-06-13

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

Patient Information Center iX; Software Version Number: 4.5.0

Reason for recall

A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.

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