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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94185

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 28, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

Z-1386-2024
Recall number
Z-1386-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America
Quantity
257,183 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: (01)00884838104594(10)4.0.1 (01)00884838104594(10)4.0.2 (01)00884838112070(10)4.1.0 (01)00884838112070(10)4.1.1 (01)00884838121782(10)4.2.0 (01)00884838121782(10)4.2.1; Serial Numbers: 7G6G-7PGV-W 5971-2NL7-Z 6D62-19MD-9 463N-67ME-X 5K2A-6DHP-K 5E42-35J4-P 4E6Z-70HU-B 1T12-0MNA-C 2H34-3MMP-U 6P1E-7HJU-W 3R6X-3XNY-6 7F50-53NK-L 3Z3B-1AHM-H 0C5Y-7FHX-V 0X7R-2AGC-Y 0P5D-5VMH-V 6627-6MKH-U 5J7B-1XPT-T 7U4C-44NB-E 2Y7R-5KGZ-W 1P22-0XNW-P 1004-6RJX-E 1U0P-0FKE-C 396T-5ZH1-5 610R-7AHH-2 0B5K-10GT-X 0Z7K-0VKT-0 2A5D-1NH8-Y 2Y5M-5AGH-E 3153-2END-M 4H2B-5YJP-0 5F6T-6XMZ-Y 5Y3Z-2RHR-N 6B6G-3DKJ-4 7Z05-0UH7-V 5H6A-2ZKV-1 1J61-2KH5-M 612A-2WG5-W 737K-7LPC-G 7Z3Y-0LJ3-2 3T0R-7AHH-X 7A4Y-78J7-V 2P5H-0JLM-Y 002A-5MGJ-6 0X63-19MD-G 221G-5NMA-3 4W6U-0PLF-2 7A3M-6VGP-H 7J0C-69LP-H 0V4G-0EG2-B 2K1C-42GL-Y 4M77-1HM0-G 4R5J-5AGH-B 4T62-19MD-7 4W08-0UH7-U 5Y2X-65P4-E 6H5T-3FHA-4 6K59-0HN3-B 2X7R-5KGZ-Z 016X-52P8-4 041V-48PE-D 0A61-74NU-C 0J71-6UGD-Z 0P4Y-78J7-V 0R1W-2MNL-2 0T41-35J4-A 0V7B-4EJH-A 0W65-4PJB-V 1036-4KHG-N 156Y-70HU-R 1A4K-2BNM-C 1D5N-0YG8-K 1Y2E-0NNG-X 1Z7W-00G0-F 2141-35J4-G 2630-65P4-3 2A5H-1YML-U 2K53-2END-0 2M2G-15LB-E 2N78-6CPV-9 2V3T-67ME-K 2X44-7ELE-J 2X46-12JD-H 2Z73-2NL7-2 302H-6LPP-W 3107-4RG3-6 375F-7UMF-K 3B54-58M8-P 3K33-61K2-0 3Z4R-2LKY-9 483K-28MC-M 4J6V-6XMZ-R 4N5A-1NH8-5 4T7D-4EJH-E 4V52-30PD-F 4V6C-1PJ5-R 521J-18LJ-5 591J-18LJ-G 5A4L-1CJJ-J 5A4T-57JE-R 5C4L-7WMK-2 5F72-2NL7-Y 5G1Y-1WJ2-5 5Y6J-3HL1-E 6031-24GX-X 684V-57JE-Z 693T-6YM2-Y 6D2X-1BLC-4 6F3G-46MR-K 6L0D-02P6-4 6M5J-0JLM-H 6N1K-25G7-8 6U32-24GX-0 6Y79-1HM0-M 6Z1H-1KG1-6 6Z5N-0YG8-R 724E-34MB-4 7U76-1HM0-D 7Y5Z-7FHX-F 4L7J-7MPL-J 0D6E-39G4-P 5B0U-08NR-E 6F2V-1BLC-W 003W-3UN7-M 2V57-6TKK-N 3D5U-2PJT-3 3T5P-0YG8-Y 0N1E-7HJU-5 1J5H-1YML-3 1W6W-21KC-Z 284W-72P0-G 325N-73HZ-G 4U39-3JGK-2 5G2W-1VNP-A 5L5X-32PN-Z 617X-31N5-0 017L-0VKT-B 067L-7MPL-2 116V-21KC-Z 116Z-1ZL8-V 1305-0UH7-M 1K1B-1EGA-D 2P1T-75JN-B 3055-68PX-3 350Y-2DMM-7 3A0H-6AMX-6 3V31-7NPM-F 414L-03P1-E 4R03-1FHE-U 4R1J-18LJ-4 523N-67ME-8 5X3N-67ME-P 623Z-2RHR-9 6633-24GX-D 670F-60JV-1 6L0F-60JV-U 713Z-3UN7-Y 7676-1HM0-9 7C5C-7UMF-D 1135-04K8-Z 094B-40KU-3 2C6N-3KLU-C 2V2W-3VM1-X 545X-32PN-F 706P-0PLF-0 6X1X-3CH6-V 264N-2LKY-K 3C44-7ELE-4 3K0J-6GLT-B 6T49-44NB-Z 2V51-29H4-H 4K30-5BNT-7 5N40-2RHR-N 0Y0L-0FKE-E 3F5L-5AGH-9 6U2G-3YNZ-J 032M-79HL-V 115M-4LGG-4 2L0L-0FKE-A 0D1V-48PE-J 4L7Y-00G0-F 567W-7BG9-5 6E64-7XLV-M 6J3E-0KN0-2 534U-57JE-Y 472X-65P4-L 7T0A-02P6-1 0U28-2WG5-M 0F6V-6XMZ-5 0T1M-18LJ-R 0Y5Z-7FHX-N 1256-68PX-G 1R44-7ELE-2 2W26-0CKW-V 3Z3G-0KN0-0 4H5T-0YG8-P 4R0G-60JV-1 5K0P-17M9-H 6L3G-46MR-4 3F3D-41PZ-F 661M-4HGE-D 5G2A-6DHP-W 6M6N-0DN4-G 121R-22HW-3 7W3Y-0LJ3-B 4W2V-3VM1-7 6R2J-47P7-9 0K6E-39G4-5

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 2 of 2

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

Z-1387-2024
Recall number
Z-1387-2024
Initiated
February 28, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America
Quantity
2,323 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

Worldwide - US Nationwide distribution.

Field note

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