Class II Recall

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

Summary

The FDA issued a Class II for CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Up by Philips North America. 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 w.

Details

Source

Device Recall

External ID

Z-1387-2024

Action Date

2024-04-03

Status

Ongoing

Product Description

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

Lot/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 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

Quantity Affected: 2,323 Units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-02-28

Company

Philips North America

Cambridge, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Philips North America has 126 FDA actions in our database, including 126 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Philips North America have FDA actions?

Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1387-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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