BEUDAMED
    FDA Enforcement Class II Ongoing

    Allura Xper FD20; Model Number: 722012;

    Recall: Z-1070-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1070-2026
    Event ID
    98109
    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
    January 21, 2026
    Initiation Date
    December 15, 2025
    Classification Date
    January 13, 2026
    Address
    Veenpluis 4-6, Best, N/A, Netherlands

    Description

    Allura Xper FD20; Model Number: 722012;

    Reason

    Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

    Code Info

    Model Number: 722012; System Product Name: Allura Xper FD20; UDI-DI: 00884838059054; Serial Numbers: 2942, 1515, 1189, 1594, 535, 1964, 2156, 2742, 2092, 1673, 1803, 1655, 2020, 1973, 2037, 1853, 2098, 1248, 1082, 1576, 1057, 1129, 646, 930, 1421, 462, 203, 627, 2005, 1428, 353, 288, 191, 1994, 1802, 156, 853, 1283, 1956, 2361, 1980, 872, 931, 1295, 2513, 1090, 1374, 468, 1822, 812, 1379, 1817, 1580, 1050, 309, 144, 1841, 1845, 1468, 558, 1968, 1959, 2168, 1168, 1562, 967, 2114, 47, 167, 2091, 2053, 604, 603, 217, 2918, 373, 850, 1820, 1821, 1619;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.

    Quantity

    79 units