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FDAFDA · Food and drugs·Recall number Z-1386-2024

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

Published April 3, 2024 · Recall initiated: February 28, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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 to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips North America
Distributor
Worldwide - US Nationwide distribution.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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