BEUDAMED
    FDA Enforcement Class II Ongoing

    DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

    Recall: Z-0464-2026 · Reported November 19, 2025

    Enforcement

    Recall Number
    Z-0464-2026
    Event ID
    97748
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Medical Systems DMC GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2025
    Initiation Date
    October 1, 2025
    Classification Date
    November 7, 2025
    Address
    Development And Manufacturing Ctr., Rontgenstr. 24, Hamburg, N/A, Germany

    Description

    DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

    Reason

    Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.

    Code Info

    1. Model Number: 712031; UDI-DI: 00884838065321; Serial Numbers: 10001181, 10001182, 10001185, 10001186, 10001188, 10001189, SN16000022, SN20000013; 2. Model Number: 712032; UDI-DI: 00884838074514; Serial Numbers: 10001179, 19000341, 19000342, 19000343;

    Distribution

    Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,

    Quantity

    12 units