FDAClass IIApril 3, 2024

CareEvent Event Management System recall

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

Why was CareEvent Event Management System recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Recalling firm
Philips North America
Quantity
2,323 Units
Distribution
Worldwide - US Nationwide distribution.
Recall date
April 3, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls