Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Softw
Summary
The FDA issued a Class II for Patient Information Center iX, Product Code 866386, and Patient Information Cent by Philips North America. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0035-2025
Action Date
2024-10-16
Status
Ongoing
Category
device
Product Description
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Lot/Code Info: 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 073G-46MR-H 145L-55J9-B 4Y55-68PX-8 5C19-6NGR-Z 6D3Z-2RHR-8 162M-79HL-H 6521-07LZ-0 7N69-1PJ5-H 191D-50P2-0 4P5V-11KG-2 661U-5LH0-D 7F0U-08NR-0 2A24-5CKL-R 5F5X-32PN-E 0U18-2JPY-C 386B-3BNE-E 714V-7RPJ-P 7676-1HM0-9 094B-40KU-3 0V1T-7TJA-T 0V4H-1CJJ-H 6H1X-3CH6-Z 0V75-1LMN-3 3B54-58M8-P 5674-27LY-V 5F1P-6PKN-Y 5K1J-18LJ-J 283A-13JG-H 4630-5BNT-E 4N5A-1NH8-5 5P3N-67ME-9 6V56-0HN3-0 113C-20JM-4 2V51-29H4-H 5U0D-63JK-G 7438-16GM-R 085D-5VMH-8 175C-7UMF-2 1D6D-1JPH-6 2K4U-45K5-U 3C44-7ELE-4 4A6T-5ZH1-1 6W4V-7RPJ-7 273A-13JG-L 2561-74NU-T 6627-6MKH-U 0C1E-7HJU-3 2W3P-51MJ-B 5M2X-65P4-9 2816-1MHK-7 0K25-14LG-Z 460H-6AMX-H 4U2P-6HHJ-T 6D62-19MD-9 2Y2R-05HF-5 4W2V-3VM1-7 5P0P-3TLN-5 6V7B-1XPT-X 754R-5GPU-Y 691X-3CH6-P 024J-7WMK-3 1036-4KHG-N 135C-7UMF-E 4L0Y-2DMM-T 545X-32PN-F 5A4T-57JE-R 623Z-2RHR-9 730U-08NR-4 4X2K-2TP9-Z 692U-1BLC-X 7G6G-7PGV-W 4R2V-3VM1-K 591J-18LJ-G 1K1V-48PE-Z 3Y2E-7YK1-C 6H5F-0ZNF-M 7769-1PJ5-Y 794M-43JR-U 7E4F-1GL2-T 087H-7LPC-6 0N48-4XM7-X 0R1W-2MNL-2 077H-7LPC-9 6L4V-7RPJ-Z 7T4G-0GN9-Z 2M3U-6ZJ1-2 5G6X-3XNY-W 6P76-1HM0-P 1U24-5CKL-9 1W3A-13JG-N 1Z4K-2BNM-D 2213-59N8-R 2M7Z-71KX-H 5L1U-5LH0-4 704D-0EG2-2 0J5L-55J9-2 115M-4LGG-4 2E67-33KR-A 7E17-4CLX-R 455V-11KG-R 0Y2W-7DL9-1 2646-12JD-N 553D-41PZ-B 5A2X-65P4-A 5H21-07LZ-X 687M-2AGC-4 7P4B-40KU-J 2L0L-0FKE-A 573H-5PP3-L 244U-45K5-7 284W-72P0-G 4W7V-7BG9-K 521J-18LJ-5 5F1U-5LH0-K 0P4Y-78J7-V 2M5R-3FHA-B 2X44-7ELE-J 5L2N-0WPA-N 6X64-7XLV-8 084H-1CJJ-A 0M36-4KHG-R 170W-0TLA-3 1879-49M4-P 1E3V-3PJ8-Z 1T4K-2BNM-Z 2D6Z-1ZL8-N 2G7Z-71KX-0 4A66-5XN6-U 4C66-5XN6-L 4F7F-0BLD-V 5D52-30PD-R 5N1L-1TLH-3 5N3Z-2RHR-E 6C4V-7RPJ-P 6N4Z-6KKD-E 7A3T-6YM2-U 1H7N-5FNJ-T 4W2Z-3RLW-L 061T-7TJA-R 756G-7PGV-X 0Z7Y-76MW-6 1015-5DJ6-B 264N-2LKY-K 2P12-0MNA-H 5A5Z-2KH5-G 2Z1G-5NMA-C 332B-5YJP-B 3B7R-5KGZ-L 4V4T-57JE-6 6P3W-3UN7-A 121R-22HW-3 2C0L-0FKE-2 2T2H-6LPP-J 317W-00G0-7 523N-67ME-8 6L0U-08NR-J 767A-4EJH-H 687B-1XPT-N 6T69-1PJ5-9 0F4Y-78J7-K 4U39-3JGK-2 1Y2E-0NNG-X 5G2W-1VNP-A 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2N3V-6YM2-X 5A7E-1XPT-4 2F7X-31N5-U 552R-79HL-3 016X-52P8-4 7H5W-2PJT-M 6419-2JPY-T 622Z-7NPM-Y 730B-02P6-L 4Z26-14LG-8 3830-3RLW-T 7X3Y-7ZPB-P 6R5M-55J9-V 720K-6GLT-B 603J-5PP3-T
Quantity Affected: 591 devices
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-19
Company
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 123 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-0035-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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