FDA Device recall Z-1387-2024
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X by Philips North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1387-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-28 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI: (01)00884838099128(10)C.03.00; Serial Numbers: 5T6W-21KC-4 3L0R-7AHH-C 1F1G-01JC-6 415A-26K6-9 605K-5AGH-2 5J5…UDI-DI: (01)00884838099128(10)C.03.00; Serial Numbers: 5T6W-21KC-4 3L0R-7AHH-C 1F1G-01JC-6 415A-26K6-9 605K-5AGH-2 5J5G-0ZNF-4 7A6D-4TL3-Y 233Z-0LJ3-C 142W-3VM1-3 1863-19MD-E 3F0T-7AHH-C 4R5K-5AGH-W 2T5M-55J9-W 0U6Z-70HU-B 795Z-7FHX-E 2K3W-3PJ8-0 3T5Z-7FHX-2 0B13-0MNA-8 0R0E-63JK-C 644J-1CJJ-1 470D-63JK-A 2022-0XNW-V 5W2A-5MGJ-D 0141-2RHR-B 6944-5RM5-A 7G7Y-76MW-C 0L09-3WPK-J 2R1E-50P2-3 3967-33KR-R 3H3M-28MC-X 4E1V-5LH0-8 5Y57-68PX-9 150B-02P6-L 3W5D-7UMF-J 0C33-3MMP-U 181U-7TJA-2 2V6Z-1ZL8-C 2468-33KR-T 0J1J-1KG1-4 591H-1KG1-9 194W-72P0-E 2Y57-6TKK-D 2W0U-6WNX-P 7L3W-3PJ8-R 2044-77KZ-8 2G1U-7TJA-9 6E7C-1XPT-M 7L0M-4AH2-1 0U41-6BK3-L 6G5N-4LGG-3 232E-2FMY-X 6R22-07LZ-R 1P5K-5AGH-2 2378-6CPV-2 0550-53NK-T 0F13-59N8-K 1M4Y-78J7-0 0B5Z-7FHX-F 4C04-4ZPR-E 0V6H-7PGV-K 4T3C-1AHM-K 4673-5WKF-5 1F6P-0PLF-T 4F0B-02P6-K 5327-0CKW-L 023M-4WMG-F 490H-6AMX-8 007P-5FNJ-Y 696N-3KLU-H 4Z71-6UGD-L 622C-0NNG-A 4D2U-1VNP-J 5P2P-79HL-W 4B22-07LZ-1 6T6P-0PLF-N 1D7K-0VKT-M 2C5V-11KG-5 6H2D-2FMY-Y 4468-7VM |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1387-2024%22
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