BEUDAMED
    FDA Enforcement Class II Ongoing

    (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424

    Recall: Z-0731-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0731-2024
    Event ID
    93638
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2024
    Initiation Date
    November 28, 2023
    Classification Date
    January 13, 2024
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    Description

    (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424

    Reason

    Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

    Code Info

    UDI-DI: (1) 00884838104594 (2) 00884838112070 (3) 00884838121782 Software: PIC iX Version 4.X

    Distribution

    Worldwide distribution: US (Nationwide) to states of: CA, GA, IA, MA, MI, MN, NJ, NM, NY, OH, PA, TN, TX, WA, WV; and OUS (Foreign) distribution to countries of: Australia, Austria, Belarus, Belgium, Brazil, Canada, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, India, Indonesia, Ireland, Italy, Japan, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd.Arab.Emir., and Uzbekistan

    Quantity

    41 US; 773 OUS