Philips North America Llc: Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

Recall number

Z-1827-2024

Recalling firm

Philips North America Llc

Product

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

Status

Open, Classified

Initiated

2024-04-19

Posted

2024-05-15

Terminated

not on file

Reason

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

Root cause

Software design

Action

Consignees were sent an "URGENT Medical Device Correction," notification, dated 4/12/24. Consignees are instructed in the notification to review in Events Monitor and confirm the expected category is assigned for the reviewed event. If events are not assigned to the correct category consignees are not to depend on event notification for patient monitoring. The provided recall notification should be provided to all users of affected devices and to those the device was further distributed, for their awareness. Philips will contact consignees to schedule a visit from a Philips Field Service Engineer to provide a software patch (PIC iX 4.2.4) to correct the issue. Consignees with any questions are to contact their local Philips representative or call 1-800-722-9377.

Quantity

358 units (US: 45; OUS: 313)

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.

Lot, serial or model codes

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, .

510(k) numbers

["K153702"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3016618143

Firm city

Cambridge

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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