FDA recall Z-1387-2024

Philips North America · Class II · device

Product

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-02-28
Report date: 2024-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1387-2024