Z-1387-2024 Class II Ongoing
FDA device recall Z-1387-2024 was initiated by Philips North America on Feb 28, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2,323 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2024
- Initiation Date
- Feb 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,323 Units
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
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 4468-7VM6-B 1F40-2RHR-F 5857-68PX-B 0V4U-45K5-4 5D2H-15LB-L 6F01-38KA-0 6W2M-1RHT-G 0816-5DJ6-5 0U2P-0WPA-U 0D7G-0BLD-N 7B7Y-2CJW-7 0372-6UGD-X 1F0H-23HD-C 3E3T-7KGB-Y 4Z6T-5ZH1-2 176C-3BNE-4 042E-2FMY-W 0X26-14LG-J 4152-30PD-X 6A40-2RHR-T 3C02-71KX-X 657A-49M4-C 0V3W-3PJ8-A 1T6X-1UP5-6 0F4U-57JE-Z 041G-01JC-8 621E-50P2-1 1C67-5XN6-8 686B-7VM6-G 5X4B-40KU-2 3K1U-7TJA-Z 6320-1DNN-P 2H3U-6YM2-V 4Z2W-3VM1-F 1T7E-2UGW-Z 4N03-5TLL-9 2W3V-3PJ8-L 0E08-3WPK-K 3W1U-7TJA-4 7Y6B-2ZKV-9 2B1V-48PE-N 1327-0CKW-R 6A0A-64MU-1 2C7U-4VK7-C 2A5E-5VMH-H 3Z15-4JK4-P 0N24-4YL5-9 4C58-6TKK-J 3R18-5DJ6-L 0607-4DL4-0 5N1E-50P2-6 2V22-07LZ-K 0923-4YL5-Z 1678-09GU-P 4H48-7GN2-R 1A6R-0PLF-T 6K3J-5PP3-0 2D5V-2PJT-M 6K66-4PJB-1 4M2A-5MGJ-3 7A7A-49M4-W 2405-6RJX-J 4V31-5BNT-0 021E-42GL-M 2A00-2CJW-G 110X-3GJ0-Y 3U73-5WKF-A 7Y4K-7WMK-T 7C53-30PD-A 0X61-5UGY-D 2K0X-0TLA-F 3X3X-7ZPB-A 075K-0JLM-J 0P7L-7MPL-F 0R7M-0VKT-P 0U04-4ZPR-8 155C-6JK9-3 1F67-4PJB-3 2D5Z-7FHX-7 2P17-4JK4-J 393L-6VGP-7 3A3B-13JG-V 3K2F-2FMY-X 4K3E-41PZ-K 522M-47P7-Z 5707-4RG3-J 6L6D-4TL3-1 7A2E-0NNG-K 1H45-7ELE-8 203A-13JG-9 3Y39-16GM-Z 6P54-2END-1 6X5H-0ZNF-K 783Y-7ZPB-N 790U-6WNX-B 7Z7Y-2CJW-B 0547-7GN2-F 0A28-6MKH-5 0D5Y-7FHX-R 0M4R-37N1-6 0R1L-18LJ-A 1B2F-15LB-W 1K7A-49M4-7 1R1A-0ALR-U 200L-4FL0-P 235N-4LGG-E 2815-5DJ6-J 2B43-5RM5-P 2F6V-21KC-L 2M16-1MHK-0 2M5J-5AGH-N 3Z3Y-7ZPB-M 460L-6GLT-K 4A7V-7BG9-9 4K6B-2ZKV-D 4U1N-75JN-D 5F3P-67ME-J 5K0H-23HD-W 5P7F-0BLD-2 5W1F-01JC-A 6W65-7XLV-W 7D7Z-76MW-6 7R31-24GX-L 2J40-6BK3-T 4W5N-4LGG-1 0B1N-4HGE-M 0C5N-4LGG-M 0N70-1ZL8-5 0W3U-6ZJ1-F 1D2L-2TP9-3 1E0T-7AHH-H 1J0D-69LP-8 1K0L-4FL0-Z 1K2K-47P7-E 1T5L-55J9-C 2P0Y-6FKB-G 313C-1AHM-W 3721-0XNW-L 454V-45K5-K 4B3T-7KGB-6 5955-58M8-C 6058-6TKK-L 6212-4GJY-9 6B2K-47P7-1 6Y7W-4VK7-L 720X-0TLA-X 745F-0ZNF-V 7P1X-48PE-F 1828-6MKH-A 0M18-2JPY-V 1H22-36KM-9 1X26-5CKL-2 286H-7PGV-A 3G1U-22HW-T 3M01-76MW-K 474Y-5JHY-T 4A35-3ALK-J 5051-53NK-L 6T6R-0DN4-6 752N-79HL-Z 7749-4XM7-L 797B-49M4-G 000Z-2DMM-A 005C-6JK9-K 0257-68PX-2 060G-4MHC-L 0777-27LY-G 0812-4BPG-Z 0908-4DL4-8 0C6V-6XMZ-E 0G64-74NU-D 0J4X-7RPJ-D 0L61-5UGY-8 0M50-78J7-U 0V5P-0YG8-V 0W4Z-78J7-X 0X4M-2BNM-N 0Y1J-1KG1-0 0Z3N-4NPW-T 1070-70HU-0 165X-2VNH-X 177U-56K0-D 183W-6ZJ1-C 1F3V-6ZJ1-6 1J72-2NL7-T 1L4B-2HJF-U 1L4G-0EG2-Z 1L74-3ZKP-E 1P0L-4FL0-K 1U5M-5AGH-V 1Z07-0UH7-3 1Z7H-06MT-4 1Z7K-7MPL-5 2253-30PD-D 250G-60JV-W 2809-3WPK-L 287W-7BG9-2 2B0L-4FL0-N 2D5L-73HZ-E 2N0V-6WNX-U 2N70-70HU-X 2N7X-00G0-U 2P5N-4LGG-J 2Y3J-6VGP-7 2Y4G-1GL2-Z 2Z37-04K8-6 303G-0KN0-X 3046-12JD-7 3245-54M3-H 326C-1PJ5-4 3326-0CKW-5 365R-0YG8-8 3A6N-3KLU-H 3D42-6BK3-9 3E20-0XNW-E 3H7H-0BLD-R 3L2C-6DHP-L 3L5H-0JLM-6 3N4Y-72P0-7 3N61-5UGY-Z 3P10-2GGN-B 3V3G-4UJL-D 3V7U-5KGZ-6 4036-04K8-G 407T-5KGZ-5 430T-3TLN-4 4356-68PX-A 4L6G-3DKJ-B 4N7P-5FNJ-R 4U7W-31N5-6 4V7U-31N5-1 4Z1H-01JC-4 514E-34MB-9 533E-41PZ-2 542B-5MGJ-6 5565-19MD-M 560U-6WNX-N 5E19-2JPY-W 5G3R-67ME-0 5L29-6MKH-K 5L7L-0VKT-D 5N22-07LZ-Z 5P4E-0EG2-G 5U02-1FHE-2 6161-5UGY-V 624M-03P1-U 633E-0KN0-F 642P-79HL-L 6644-77KZ-J 674V-45K5-B 687U-4VK7-L 6C0V-08NR-V 6C37-4KHG-Y 6D7C-62PF-J 6E65-7XLV-6 6E6W-21KC-4 6G55-58M8-N 6R4M-2BNM-Z 6X0C-3EH3-G 6X0R-17M9-3 706W-21KC-D 711C-0ALR-V 726K-0RGF-5 741T-22HW-8 750D-3EH3-8 7557-0HN3-J 756U-6XMZ-B 760T-6WNX-3 7836-04K8-M 7940-2RHR-V 7F1F-7HJU-4 7F4M-43JR-8 7F4X-45K5-L 7K1U-22HW-C 7L5N-4LGG-N 7N6U-6XMZ-R 7V04-5TLL-8 7V2V-05HF-W 7V62-5UGY-X 0774-3ZKP-N 1V15-5DJ6-U 235L-73HZ-C 3Z4F-34MB-2 4608-4DL4-D 512A-5MGJ-Y 5N5P-0YG8-5 6V06-4RG3-4 741Z-1WJ2-R 0L3K-6VGP-R 1F1B-0ALR-6 2C5E-5VMH-B 3C7A-49M4-U 6J07-4RG3-G 6P61-5UGY-T 6R6K-0RGF-4 7B3W-3PJ8-K 0K2M-1RHT-H 1H6G-1JPH-D 1Y3R-67ME-U 2C1K-1KG1-5 2H75-3ZKP-7 4004-5TLL-W 5L5K-0JLM-6 744N-03P1-4 7Z1F-50P2-U 5L16-5DJ6-W 6R6U-52P8-6 0375-27LY-U 0931-5BNT-U 0A4A-44NB-3 0U56-68PX-9 0V6Z-70HU-8 0W5J-10GT-T 1235-3ALK-D 137C-4EJH-2 152J-47P7-7 1A7H-7LPC-Z 1J73-2NL7-A 1T6W-52P8-A 2B38-4KHG-N 2G2K-47P7-N 3605-5TLL-W 387B-49M4-P 3B72-6UGD-2 3F5Z-32PN-J 483D-41PZ-3 4E3U-7KGB-E 4G0A-64MU-H 4J1D-42GL-G 4L4Y-5JHY-J 4N4W-7RPJ-C 4N68-33KR-1 4U1J-1KG1-8 522N-79HL-A 5955-68PX-6 595X-32PN-0 5B7G-2UGW-7 5F2J-6LPP-Y 5L33-61K2-V 5M7N-2AGC-F 5N36-3ALK-Y 5P4U-5GPU-C 614P-37N1-B 624D-40KU-L 6330-3RLW-5 6H72-6UGD-D 717L-7MPL-A 774G-1GL2-Z 7A29-0CKW-Z 7B0H-23HD-J 7T2Z-65P4-X 7U0D-69LP-A 7W2F-7YK1-Z 7W46-54M3-G 150E-63JK-4 3X1H-5NMA-2 5F43-6BK3-J 3F73-5WKF-B 641X-2MNL-9 047L-0VKT-2 073E-0KN0-9 074Y-5JHY-X 321K-5NMA-M 3A6H-7PGV-3 5958-0HN3-T 6H2Y-65P4-5 086V-52P8-D 0V29-6MKH-3 1R2N-79HL-C 1U2B-5YJP-8 4T0A-64MU-N 5R0V-08NR-R 7T4A-2HJF-L 101T-7TJA-9 7E5T-66H9-D 2C47-7GN2-R 2K6H-3HL1-1 2M71-6UGD-L 4818-4CLX-Y 5U7F-0BLD-T 5Y1M-1TLH-W 6K48-7GN2-G 6P35-3ALK-9 7F0V-6FKB-G 064Y-78J7-E 0M74-3ZKP-C 0U4A-4XM7-K 0Y6E-39G4-4 1B6E-39G4-W 1F2W-7DL9-D 1M47-7GN2-Y 1M5L-55J9-R 1M74-3ZKP-B 1N5H-0ZNF-D 2710-2GGN-W 2C0G-60JV-7 2F5N-4LGG-A 2T15-59N8-M 2U4V-45K5-N 313P-51MJ-V 354G-34MB-1 3B6K-3NNV-D 3N45-77KZ-N 3N4G-1GL2-N 460E-4MHC-E 4615-4JK4-1 4J0Z-2GGN-H 4R16-5DJ6-H 4W2L-47P7-1 512V-3VM1-P 5D5A-1NH8-Z 5W0A-64MU-C 5Z7M-7JG6-7 611V-22HW-L 6511-2GGN-F 651G-7HJU-L 676F-39G4-L 6A5H-10GT-R 6E0E-63JK-4 6W4D-0EG2-F 6Z31-24GX-0 785K-73HZ-7 7B4G-0GN9-9 7N7K-7LPC-P 5B1T-6PKN-C 1P3M-4WMG-F 125Z-7FHX-9 143A-13JG-Y 0E0E-63JK-A 0F10-2GGN-6 0N7K-7CNC-Z 0R1M-4HGE-X 0T4J-0GN9-8 0U14-59N8-3 0W64-5EHN-E 0Y2J-47P7-X 153X-3UN7-N 180D-69LP-6 1964-5EHN-6 2R3K-6VGP-A 392A-5MGJ-8 3L1J-1KG1-V 4426-14LG-T 4T1X-3CH6-9 5259-6TKK-0 5C7L-0VKT-5 5M4Z-6KKD-J 5Z4R-2LKY-7 6A6D-4TL3-Z 6T18-4CLX-9 6V5D-7UMF-J 735A-26K6-0 7N7D-62PF-7 7V0B-3WPK-R 7W5X-2VNH-M 2U0H-23HD-A 136H-7PGV-U 6F1L-1TLH-P 574R-37N1-B 1X0H-23HD-2 604G-1GL2-M 7F2Y-65P4-A 1H3G-41PZ-Y
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1387-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026