Recall Z-3141-2026— Philips North America

Name: FDA recall Z-3141-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2026-07-31. It names one FDA 510(k) clearance: K153702. Product: Philips Patient Information Center iX REF:866389. Reason: Due to software malfunction, patient information system may freeze and become unresponsive..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2026-07-31
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

Philips Patient Information Center iX REF:866389

Reason for recall

Due to software malfunction, patient information system may freeze and become unresponsive.

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