Recall Z-1387-2024— Philips North America

Name: FDA recall Z-1387-2024
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: K161164. Product: CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.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

K161164 — CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems·cleared 2016-06-24

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

CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.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.