BEUDAMED
    FDA Enforcement Class II Ongoing

    Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    Recall: Z-2628-2025 · Reported October 1, 2025

    Enforcement

    Recall Number
    Z-2628-2025
    Event ID
    97501
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2025
    Initiation Date
    September 3, 2025
    Classification Date
    September 25, 2025
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    Reason

    Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

    Code Info

    Product Codes: (1)722023, (2) 722035, (3) 722015; UDI-DI: (1) 00884838059085, (2) 00884838054240, (3) N/A; Serial numbers: (1) 27, 116, 12, 175, 98, 35, 142, 179, 46, 64, 110, 124, 66, 117, 109, 42, 138, 82, 83, 127, 75, 118, 41, 121, 70, 119, 112, 25, 159, 137, 47, 173, 114, 167, 164, 4, 16, 14, 107, 9, 13, 105, 5, 132, 2, 21, 38, 102, 52, 84, 56, 150, 144, 149, 134, 60, 15, 68, 126, 79, 145, 123, 135, 157, 32, 53, 152, 108, 95, 34, 87, 94, 57, 58, 165, 86, 125, 103, 3, 31, (2) 123, 38, 85, 101, 117, 21, 57, 145, 119, 100, 47, 127, 52, 131, 124, 89, 46, 74, 59, 121, 34, 72, 111, 128, 84, 10, 11, 40, 108, 144, 266, 80, 113, 130, 122, 109, 96, 53, 58, 104, 56, 69, 71, 75, 76, 208, 110, 149, 49, 105, 82, 136, 15, 146, 48, 16, 95, 64, 17, 106, 81, 29, 116, 102, 13, 12, 32, 35, 62, 107, 142, 43, 77, 94, 33, 37, 61, 51, 50, 19, 28, 97, 148, 114, 3, 151, 79, 129, 65, 25, 26, 103, 98, (3) 3;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

    Quantity

    174 units (45 US, 129 OUS)