BEUDAMED
    FDA Recall Open, Classified

    Patient Information Center iX; Software Version Number: 4.5.0

    Recall: Z-1156-2026 · Initiated December 22, 2025

    Recall

    Recall Number
    Z-1156-2026
    Event Number
    98217
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    December 22, 2025
    Posted
    January 22, 2026
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    Description

    Patient Information Center iX; Software Version Number: 4.5.0

    Reason

    A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.

    Action

    On or about December 22, 2025 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: Review the Mobile Notification Event Filters settings and confirm all the events intended to be sent to mobile devices automatically are enabled for Mobile Notification Event Filters. " Pass this notice to all those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred. Actions planned by Philips to correct the problem " Philips representative will contact you to obtain PIC iX 4.5.1 SW patch for PIC iX systems running software version 4.5.0. If you need any further information, please contact your local Philips representative, or call (800) 722-9377.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Utd.Arab.Emir.

    Quantity

    146 units (41 US, 105 OUS)