Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
FDA Recall Z-1827-2024 · Posted 2024-05-15
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Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2024-04-19
Product Quantity358 units (US: 45; OUS: 313)
Reason for Recall
Event Catalog information does not save when copied and transferred from one unit to another.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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