BEUDAMED
    FDA Enforcement Class II Ongoing

    Precision CRF; Model Number: 706400;

    Recall: Z-0463-2026 · Reported November 19, 2025

    Enforcement

    Recall Number
    Z-0463-2026
    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

    Precision CRF; Model Number: 706400;

    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

    Model Number: 706400; UDI-DI: 00884838110588; Serial Number: 19, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 10001178, 10001179, 10001181, 10001182, 10001184, 10001185, 10001186, 10001187, 10001188, 10001189, 10001190, 10001191, 10001192, 10001193, 10001194, 10001195, 10001196, 10001197, 10001199, 10001200, 10001201, 10001202, 10001203, 10001204, 10001205, 10001206, 10001208, 10001209;

    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

    42 units