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FDAFDA · Food and drugs·Recall number Z-0035-2025

Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

Published October 16, 2024 · Recall initiated: April 19, 2023

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

During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips North America
Distributor
Worldwide - US Nationwide distribution.
Lot
UDI-DI: 00884838104594; Serial Numbers:0Y5Z-7FHX-N 5H20-1DNN-E 1762-74NU-5 1C0V-08NR-0 6U53-30PD-1 6M5J-0JLM-H 2M2G-15LB-E 4U3A-3JGK-K 0439-16GM-G 3A1T-22HW-U 534U-57JE-Y 0D6U-5ZH1-D 3H5C-6JK9-X 3K0C-3EH3-H 3Z47-12JD-V 524N-43JR-2 5N40-2RHR-N 1331-5BNT-B 1V4F-34MB-G 1B4R-37N1-3 6D3L-28MC-M 7Y52-29H4-L 7Y5Z-7FHX-F 1X6W-21KC-W 6278-09GU-Y 2C6N-3KLU-C 3E5Y-32PN-4 5T2L-2TP9-V 021Z-1WJ2-5 1W6W-21KC-Z 7L3H-46MR-L 194D-2YHB-T 1Y7A-49M4-6 2Z3C-1AHM-3 4T51-53NK-A 1P4A-44NB-V 3B5M-55J9-5 5V57-0HN3-J 7V5Z-7FHX-R 224B-2HJF-F 5G1G-01JC-Z 6Y7F-06MT-0 676T-6XMZ-M 5F1G-01JC-2 5K2B-6DHP-4 5T45-7ELE-C 0V7B-4EJH-A 1F23-36KM-0 2C50-6KKD-R 3107-4RG3-6 3X5B-1NH8-2 6U32-24GX-0 5K2L-2TP9-D 4T2R-6HHJ-D 613L-28MC-T 7K21-0XNW-C 062U-1VNP-B 5M78-09GU-6 6226-14LG-X 0V6R-0PLF-7 5K72-2NL7-J 7G21-0XNW-M 077M-7JG6-L 2R4Y-5JHY-8 7Z4E-0EG2-N 1X2J-6LPP-R 1Y0A-64MU-A 0Z3E-41PZ-K 327Y-2CJW-6 3979-6CPV-0 2150-6KKD-T 4E6Z-70HU-B 1H3G-4UJL-D 2A75-27LY-3 3X3J-5PP3-5 4V7G-0BLD-8 567W-7BG9-5 5K6K-0RGF-L 6F2V-1BLC-W 0106-0UH7-D 1T1M-1TLH-F 5N2E-2FMY-1 057M-7JG6-U 0M5T-3FHA-Y 4B7K-7MPL-Y 4J2R-6HHJ-2 6H7F-06MT-7 184A-44NB-8 2518-4CLX-9 4Y40-2RHR-Z 5Y6J-3HL1-E 241K-18LJ-K 3R04-4ZPR-B 5B5G-0ZNF-T 4N77-1HM0-D 7W49-4XM7-M 723D-20JM-C 2V2W-3VM1-X 4T12-4BPG-8 5V3L-28MC-C 6J2K-47P7-C 2975-27LY-6 2E48-7GN2-3 2K0X-0TLA-F 302F-7YK1-P 3215-4JK4-E 3B05-6RJX-W 530G-60JV-Z 5843-5RM5-X 5J6K-0RGF-P 5U6T-6XMZ-X 684L-2BNM-Y 6K5U-66H9-G 743H-46MR-4 783K-6VGP-M 7F1U-7TJA-7 7U09-3WPK-T 0Z69-7VM6-F 1063-19MD-6 114M-03P1-2 1Y1E-50P2-J 2P5C-6JK9-C 7P27-0CKW-N 0J71-6UGD-Z 1H2D-0NNG-K 1X0A-64MU-D 3D1B-0ALR-A 620Z-2DMM-Y 6A3F-0KN0-B 0B5K-5AGH-7 333Y-7ZPB-9 6U33-3MMP-A 2U6M-2XHV-0 5F72-2NL7-Y 5K53-30PD-P 2J0X-0TLA-J 5034-61K2-8 6W2Z-7NPM-G 136A-1PJ5-1 3J5B-1NH8-3 4867-5XN6-H 6573-5WKF-6 017L-0VKT-B 0A31-5BNT-P 2J36-04K8-W 5D5J-0JLM-A 1A7A-49M4-2 0W02-1FHE-1 140F-4MHC-8 0856-68PX-Z 3R4K-7WMK-F 4G2R-6HHJ-8 7Y0V-08NR-4 027J-7LPC-9 1B0T-7AHH-U 2A1W-48PE-A 3W0K-6GLT-1 4R2H-3YNZ-B 5B72-2NL7-A 0K6R-0PLF-Z 3L13-0MNA-A 6255-58M8-0 065K-5AGH-N 156F-39G4-Z 277T-5KGZ-J 2907-4RG3-F 4E6B-2ZKV-W 5F29-2WG5-2 7L1H-5NMA-T 7N27-0CKW-T 1F4C-40KU-1 1208-4DL4-W 4R0G-60JV-1 5472-2NL7-Z 5R10-2GGN-6 7E1H-5NMA-B 7G6C-3BNE-3 3T5P-0YG8-Y 0V4F-34MB-H 3W4N-43JR-N 4R1C-1EGA-C 4Z5G-0ZNF-Y 5T5A-26K6-0 761Z-1WJ2-J 007B-4EJH-V 2F5M-55J9-U 2T2T-05HF-5 440L-4FL0-9 4V43-5RM5-5 5F6T-6XMZ-Y 711U-7TJA-H 4W2L-2TP9-K 0H63-5EHN-Y 1K01-1FHE-A 0F69-1PJ5-D 3L46-12JD-B 7A09-64MU-F 6419-6NGR-N 165D-5VMH-D 286M-3KLU-7 4W7R-5KGZ-0 5G1Y-1WJ2-5 6V52-30PD-D 726U-52P8-7 781H-1KG1-A 295M-4LGG-B 687V-7BG9-D 1Y1W-2MNL-F 776C-4TL3-N 3913-59N8-2 3H6V-21KC-D 4P5G-10GT-2 1E5N-0YG8-G 4H2B-5YJP-0 5030-5BNT-Z 5Y5U-2PJT-E 6M0P-3TLN-A 1Z0M-0FKE-V 3161-74NU-4 7127-6MKH-8 0X4G-0GN9-U 1D5N-0YG8-K 1W1D-50P2-7 1N5L-55J9-M 3204-6RJX-6 454X-5JHY-E 4R5J-5AGH-B 5V2K-2TP9-4 7U76-1HM0-D 3W35-04K8-C 604P-37N1-E 6939-3JGK-K 3T0L-0FKE-U 637V-7BG9-W 256D-1JPH-X 2M1B-1EGA-6 4H2L-1RHT-2 1K5L-55J9-Y 250N-17M9-D 4Z68-7VM6-U 5T2K-2TP9-A 1F4H-1CJJ-L 380K-4FL0-D 6R70-6UGD-N 6Y1L-1TLH-A 6Z1H-1KG1-6 003W-3UN7-M 0302-5TLL-M 1L48-4XM7-2 452Y-7NPM-6 571Y-1WJ2-0 7E2A-6DHP-0 3846-12JD-F 0G7A-4EJH-U 724E-34MB-4 1T36-4KHG-B 402H-6LPP-V 422Y-7NPM-F 0169-1PJ5-P 2L7D-2UGW-W 1W5M-4LGG-K 2215-5DJ6-4 4843-77KZ-X 5L74-27LY-H 1975-1LMN-R 7G76-1HM0-B 1T6M-3KLU-M 2D3V-3PJ8-1 3951-29H4-6 093T-6YM2-4 0P5D-5VMH-V 6X1X-3CH6-V 2015-5DJ6-A 5Z39-3JGK-J 3P7G-7CNC-6 5210-4GJY-8 5K5E-1YML-9 670P-3TLN-L 3L7E-06MT-G 6T49-44NB-Z 7U02-5TLL-9 0H4B-40KU-B 131T-7TJA-0 0N4C-2YHB-2 0W50-53NK-L 1B2M-79HL-2 1V0N-17M9-C 2479-49M4-2 2T13-59N8-K 3A3P-51MJ-0 3M12-0MNA-N 475G-10GT-J 610R-7AHH-2 650D-63JK-E 6L1L-1TLH-8 7D76-1HM0-L 7Y60-5UGY-J 4845-54M3-Y 5L5X-32PN-Z 2X46-12JD-H 0X5N-0YG8-4 505A-1NH8-6 3P2H-6LPP-P 4Z5A-1NH8-A 6D6U-52P8-7 7D1F-01JC-M 787B-1XPT-M 347K-0VKT-E 4R5V-11KG-Z 0N1E-7HJU-5 1F5C-7UMF-A 387Z-71KX-P 5T39-3JGK-4 715F-0ZNF-4 6P62-19MD-B 635Z-2KH5-4 092D-2FMY-W 0A4G-0GN9-K 1H0C-69LP-U 2J16-1MHK-9 2U4U-45K5-5 4E2E-7YK1-V 6C2N-0WPA-D 6N62-19MD-E 2205-0UH7-P 2M1A-0ALR-2 2T4U-45K5-8 3C5R-3FHA-5 425G-10GT-1 0D0M-4AH2-X 0
Risk classification
Class II
Area (FDA)
device
Country
United States

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