Z-1827-2024Class II

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

Name: Z-1827-2024 Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x
Creator: Philips North America Llc
Published: 2024-04-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-04-19 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x on 2024-04-19. FDA classified it as Class II and gives the reason as "Event Catalog information does not save when copied and transferred from one unit to another". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1827-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-19
Posted: 2024-05-15
Recalling firm: Philips North America LLC
Product: Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Event Catalog information does not save when copied and transferred from one unit to another.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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, .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1827-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1827-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-15

Product code MHX

K153702Class IIM3290B Philips IntelliVue Information Center iXPhilips Medical Systems / cleared 2016-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)