Recall Z-1386-2024— Philips North America

Name: FDA recall Z-1386-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-28

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2024-02-28. It names one FDA 510(k) clearance: K153702. Product: Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X. Reason: It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2024-02-28
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 (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

Reason for recall

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

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