BEUDAMED
    FDA Enforcement Class I Ongoing

    MAGNETOM Skyra fit. Model Number: 10849580.

    Recall: Z-2661-2025 · Reported October 8, 2025

    Enforcement

    Recall Number
    Z-2661-2025
    Event ID
    97530
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2025
    Initiation Date
    August 28, 2025
    Classification Date
    September 30, 2025
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    MAGNETOM Skyra fit. Model Number: 10849580.

    Reason

    There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

    Code Info

    Model Number: 10849580. UDI Numbers: (01)04056869006710(21)170068, (01)04056869006710(21)170053, (01)04056869006710(21)70022, (01)04056869006710(21)170049, (01)04056869006710(21)170018, (01)04056869006680(21)162078, (01)04056869006710(21)170109, (01)04056869006710(21)170039, (01)04056869006710(21)170066, (01)04056869006710(21)170023, (01)04056869006710(21)170030, (01)04056869006710(21)170004, (01)04056869006710(21)170016, (01)04056869006710(21)170077, (01)04056869006710(21)170058, (01)04056869006710(21)170002, (01)04056869006710(21)170050, (01)04056869006710(21)170010, (01)04056869006710(21)170019, (01)04056869006710(21)70026, (01)04056869006710(21)170056, (01)04056869006710(21)170061, (01)04056869006710(21)170105, (01)04056869006710(21)170017, (01)04056869006710(21)170041, (01)04056869006710(21)70032, (01)04056869006710(21)170111, (01)04056869006710(21)170048, (01)04056869006710(21)170101, (01)04056869006710(21)170100, (01)04056869006710(21)170060, (01)04056869006710(21)170099, (01)04056869006710(21)170036, (01)04056869006710(21)170007, (01)04056869006710(21)170001, (01)04056869006710(21)170009, (01)04056869006710(21)70020, (01)04056869006710(21)170112, (01)04056869006710(21)170113, (01)04056869006710(21)170054, (01)04056869006710(21)170047, (01)04056869006710(21)170046, (01)04056869006710(21)70023, (01)04056869006710(21)70027, (01)04056869006710(21)170110, (01)04056869006710(21)170095, (01)04056869006710(21)170075, (01)04056869006710(21)170011, (01)04056869006710(21)170081, (01)04056869006710(21)170044, (01)04056869006710(21)70028, (01)04056869006710(21)170043, (01)04056869006710(21)70031, (01)04056869006710(21)70008. Serial Numbers: 170068, 170053, 70022, 170049, 170018, 170106, 170109, 170039, 170066, 170023, 170030, 170004, 170016, 170077, 170058, 170002, 170050, 170010, 170019, 70026, 170056, 170061, 170105, 170017, 170041, 70032, 170111, 170048, 170101, 170100, 170060, 170099, 170036, 170007, 170001, 170009, 70020, 170112, 170113, 170054, 170047, 170046, 70023, 70027, 170110, 170095, 170075, 170011, 170081, 170044, 70028, 170043, 70031, 70008. Additional serial number added 2/25/2026: 170023. Additional serial Numbers Added 04/16/2026: 170013.

    Distribution

    Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

    Quantity

    56 units