Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Enforcement
- Recall Number
- Z-1386-2024
- Event ID
- 94185
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 3, 2024
- Initiation Date
- February 28, 2024
- Classification Date
- March 27, 2024
- Address
- 222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States
Description
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
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.
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
Worldwide - US Nationwide distribution.
257,183 Units