BEUDAMED
    FDA Enforcement Class II Ongoing

    Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

    Recall: Z-1827-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1827-2024
    Event ID
    94468
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    May 22, 2024
    Initiation Date
    April 19, 2024
    Classification Date
    May 15, 2024
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

    Reason

    Event Catalog information does not save when copied and transferred from one unit to another.

    Code Info

    Model No. 866389 and 866390. UDI-DI: n/a; Serial No. 7G6G-7PGV-W, 5971-2NL7-Z, 6D62-19MD-9, 463N-67ME-X, 6U1W-7TJA-9, 5K2A-6DHP-K, 5E42-35J4-P, 4E6Z-70HU-B, 1T12-0MNA-C, 0C0L-0FKE-4, 2H34-3MMP-U, 6P1E-7HJU-W, 3R6X-3XNY-6, 7F50-53NK-L, 3Z3B-1AHM-H, 0128-2WG5-0, 0K6E-39G4-5, 0C5Y-7FHX-V, 0X7R-2AGC-Y, 0P5D-5VMH-V, 2K0X-0TLA-F, 6627-6MKH-U, 5J7B-1XPT-T, 7U4C-44NB-E, 2Y7R-5KGZ-W, 1P22-0XNW-P, 1004-6RJX-E, 1U0P-0FKE-C, 396T-5ZH1-5, 0Y0Z-3GJ0-A, 7Y5Z-7FHX-F, 7U76-1HM0-D, 2X44-7ELE-J, 7Z3Y-0LJ3-2, 7R7A-6CPV-0, 3C44-7ELE-4, 2L0L-0FKE-A, 1V70-3XNY-9, 5A4T-57JE-R, 375F-7UMF-K, 6031-24GX-X, 2M2G-15LB-E, 2630-65P4-3, 6E64-7XLV-M, 3K33-61K2-0, 227N-7JG6-J, 6X1X-3CH6-V, 0T41-35J4-A, 4R0G-60JV-1, 414L-03P1-E, 6Y4B-44NB-J, 7C5C-7UMF-D, 1305-0UH7-M, 116V-21KC-Z, 4R1J-18LJ-4, 3A0H-6AMX-6, 4R03-1FHE-U, 5C4L-7WMK-2, 6B35-3MMP-T, 0X63-19MD-G, 350Y-2DMM-7, 2N37-04K8-1, 6Z1H-1KG1-6, 2P1T-75JN-B, 5X3N-67ME-P, 6K59-0HN3-B, 2V57-6TKK-N, 264N-2LKY-K, 0D1V-48PE-J, 6U32-24GX-0, 684V-57JE-Z, 610R-7AHH-2, 2K53-2END-0, 5G2W-1VNP-A, 5Y2X-65P4-E, 545X-32PN-F, 1R44-7ELE-2, 0R1W-2MNL-2, 2V51-29H4-H, 6T49-44NB-Z, 6B6G-3DKJ-4, 781X-48PE-W, 2M51-6KKD-E, 3055-68PX-3, 3V31-7NPM-F, 7Z05-0UH7-V, 0J71-6UGD-Z, 4R5J-5AGH-B, 116Z-1ZL8-V, 1K1B-1EGA-D, 1W6W-21KC-Z, 567W-7BG9-5, 0T1M-18LJ-R, 0F6V-6XMZ-5, 221G-5NMA-3, 4W6U-0PLF-2, 6F3G-46MR-K, 612A-2WG5-W, 1Z7W-00G0-F, 670F-60JV-1, 4T62-19MD-7, 523N-67ME-8, 067L-7MPL-2, 2J7X-2CJW-6, 017L-0VKT-B, 6633-24GX-D, 7676-1HM0-9, 4M77-1HM0-G, 3T5P-0YG8-Y, 003W-3UN7-M, 3D5U-2PJT-3, 117J-0BLD-V, 4K30-5BNT-7, 4V6C-1PJ5-R, 3T0R-7AHH-X, 325N-73HZ-G, 5Y3Z-2RHR-N, 4Y52-29H4-P, 5A4L-1CJJ-J, 724E-34MB-4, 4J6V-6XMZ-R, 156Y-70HU-R, 041V-48PE-D, 4N5A-1NH8-5, 6Z5N-0YG8-R, 2A5H-1YML-U, 5Y6J-3HL1-E, 6D2X-1BLC-4, 483K-28MC-M, 1036-4KHG-N, 6L0D-02P6-4, 5G1Y-1WJ2-5, 302H-6LPP-W, 5F6T-6XMZ-Y, 2N78-6CPV-9, 6Z6H-7PGV-1, 3F7R-56K0-H, 1J5H-1YML-3, 6R2J-47P7-9, 032M-79HL-V, 623Z-2RHR-9, 4W08-0UH7-U, 7A3M-6VGP-H, 5N40-2RHR-N, 002A-5MGJ-6, 4L7Y-00G0-F, 521J-18LJ-5, 121R-22HW-3, 1R7K-0VKT-L, 6M6N-0DN4-G, 472X-65P4-L, 3L6U-0PLF-V, 2C6N-3KLU-C, 4H5T-0YG8-P, 2A5D-1NH8-Y, 0M6B-7VM6-F, 0P4Y-78J7-V, 0A61-74NU-C, 4U39-3JGK-2, 5L5X-32PN-Z, 713Z-3UN7-Y, 7W3Y-0LJ3-B, 0Y5Z-7FHX-N, 6F2V-1BLC-W, 706P-0PLF-0, 737K-7LPC-G, 6U2G-3YNZ-J, 064C-44NB-H, 3F5L-5AGH-9, 6N1K-25G7-8, 6M5J-0JLM-H, 617X-31N5-0, 284W-72P0-G, 2K1C-42GL-Y, 0U28-2WG5-M, 1Y2E-0NNG-X, 0N1E-7HJU-5, 6L0F-60JV-U, 2V2W-3VM1-X, 1256-68PX-G, 6H5T-3FHA-4, 3K0J-6GLT-B, 591J-18LJ-G, 094B-40KU-3, 4U0A-3WPK-D, 0D6E-39G4-P, 2X7R-5KGZ-Z, 4V52-30PD-F, 0W65-4PJB-V, 115M-4LGG-4, 6N2W-7DL9-K, 2Z73-2NL7-2, 5K0P-17M9-H, 3107-4RG3-6, 2V3T-67ME-K, 5F72-2NL7-Y, 3B54-58M8-P, 1A4K-2BNM-C, 016X-52P8-4, 3153-2END-M, 0B5K-10GT-X, 3X12-2GGN-V, 0Z7K-0VKT-0, 5B0U-08NR-E, 2V03-1FHE-K, 4W2V-3VM1-7, 3Z3G-0KN0-0, 2Y5M-5AGH-E, 1D5N-0YG8-K, 0A3U-6ZJ1-5, 693T-6YM2-Y, 574E-40KU-P, 2X46-12JD-H, 4T7D-4EJH-E, 6Y79-1HM0-M, 0V7B-4EJH-A, 3Z4R-2LKY-9, 2141-35J4-G, 0V4G-0EG2-B, 4C76-1HM0-U, 2W26-0CKW-V, 5Y1Y-3CH6-A, 534U-57JE-Y, 7T0A-02P6-1, 4H2B-5YJP-0, 1J61-2KH5-M, 2L2P-6HHJ-D, 5G2A-6DHP-W, 7J0C-69LP-H, 1M6T-5ZH1-3, 6J3E-0KN0-2, 7A4Y-78J7-V, 6L3G-46MR-4, 4L7J-7MPL-J, 0Y0L-0FKE-E, 5H6A-2ZKV-1, 3F3D-41PZ-F, 661M-4HGE-D, 2P5H-0JLM-Y, 1135-04K8-Z, 7X0C-69LP-G, .

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, MA, MI, MN, MO, NJ, NM, NY, OH, PA, TN, TX, WA, WV, & DC. The countries of AE, AT, AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IN, IT, JP, KR, LT, NL, NO, OM, PL, PT, RO, SE, SG, SK, TH, & ZA.

    Quantity

    358 units (US: 45; OUS: 313)