CareEvent Event Management System — Class II medical device recall Z-1387-2024

Ongoing recall by Philips North America, reported 2024-04-03, distributed nationwide. It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom rington

Recall number	`Z-1387-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Philips North America, Cambridge, MA, United States
Recall initiated	2024-02-28
Classified	2024-03-27
Reported by FDA	2024-04-03
Distributed	Nationwide (US)
Quantity	2,323 units
UPC / GTIN / UDI-DI	`00884838099128`
Serial numbers	`000Z-2DMM-A`, `005C-6JK9-K`, `007P-5FNJ-Y`, `0141-2RHR-B`, `021E-42GL-M`, `023M-4WMG-F`, `0257-68PX-2`, `0372-6UGD-X`, `0375-27LY-U`, `041G-01JC-8`, `042E-2FMY-W`, `047L-0VKT-2`, `0547-7GN2-F`, `0550-53NK-T`, `0607-4DL4-0`, `060G-4MHC-L`, `064Y-78J7-E`, `073E-0KN0-9`, `074Y-5JHY-X`, `075K-0JLM-J`, `0774-3ZKP-N`, `0777-27LY-G`, `0812-4BPG-Z`, `0816-5DJ6-5`, `086V-52P8-D` and 475 more
Model numbers	`866435`, `866436`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1387-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.