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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2660-2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

Publicado el 8 de octubre de 2025 · Inicio del retiro: 28 de agosto de 2025

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Siemens Medical Solutions USA, Inc
Distribuidor
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.
Lote
Model Number: 10432915. UDI Numbers: (01)04056869006703(21)45046, (01)04056869006703(21)45115, (01)04056869006703(21)45398, (01)04056869006703(21)145760, (01)04056869006703(21)145811, (01)04056869006703(21)45549, (01)04056869006703(21)45834, (01)04056869006703(21)146099, (01)04056869006703(21)146110, (01)04056869006703(21)45047, (01)04056869006703(21)146093, (01)04056869006703(21)46066, (01)04056869006703(21)45788, (01)04056869006703(21)146082, (01)04056869006703(21)45124, (01)04056869006703(21)45185, (01)04056869006703(21)45332, (01)04056869006703(21)45466, (01)04056869006703(21)145390, (01)04056869006703(21)45732, (01)04056869006703(21)45918, (01)04056869006703(21)45380, (01)04056869006703(21)46182, (01)04056869006703(21)45735, (01)04056869006703(21)45233, (01)04056869006680(21)162026, (01)04056869006703(21)145008, (01)04056869006703(21)145473, (01)04056869006703(21)145095, (01)04056869006703(21)145664, (01)04056869006703(21)45200, (01)04056869006703(21)146098, (01)04056869006703(21)146086, (01)04056869006703(21)45805, (01)04056869006703(21)45812, (01)04056869006703(21)45397, (01)04056869006703(21)46264, (01)04056869006703(21)45499, (01)04056869006703(21)45749, (01)04056869006703(21)45289, (01)04056869006703(21)46220, (01)04056869006703(21)45369, (01)04056869006703(21)45267, (01)04056869006703(21)45253, (01)04056869006703(21)45060, (01)04056869006703(21)146103, (01)04056869006703(21)45333, (01)04056869006703(21)146123, (01)04056869006703(21)46147, (01)04056869006703(21)145721, (01)04056869006703(21)145840, (01)04056869006703(21)145088, (01)04056869006703(21)146124, (01)04056869006703(21)45841, (01)04056869006703(21)45890, (01)04056869006703(21)46295, (01)04056869006703(21)45306, (01)04056869006703(21)45519, (01)04056869006703(21)145905, (01)04056869006703(21)46242, (01)04056869006703(21)145806, (01)04056869006703(21)46171, (01)04056869006703(21)45148, (01)04056869006703(21)45152, (01)04056869006703(21)46194, (01)04056869006703(21)145152, (01)04056869006703(21)45119, (01)04056869006703(21)46207, (01)04056869006703(21)145549, (01)04056869006703(21)45402, (01)04056869006703(21)145090, (01)04056869006703(21)145681, (01)04056869006703(21)45877, (01)04056869006703(21)45693, (01)04056869006703(21)45679, (01)04056869006703(21)146067, (01)04056869006703(21)45140, (01)04056869006703(21)46163, (01)04056869006703(21)145635, (01)04056869006703(21)46028, (01)04056869006703(21)45138, (01)04056869006703(21)46282, (01)04056869006703(21)45479, (01)04056869006703(21)45496, (01)04056869006703(21)45143, (01)04056869006703(21)45314, (01)04056869006703(21)45368, (01)04056869006703(21)46268, (01)04056869006703(21)45998, (01)04056869006703(21)145423, (01)04056869006703(21)145190, (01)04056869006703(21)145377, (01)04056869006703(21)46005, (01)04056869006703(21)45886, (01)04056869006703(21)45905, (01)04056869006703(21)145706, (01)04056869006703(21)145684, (01)04056869006703(21)45990, (01)04056869006703(21)145063, (01)04056869006703(21)146119, (01)04056869006703(21)46260, (01)04056869006703(21)45118, (01)04056869006703(21)145062, (01)04056869006703(21)45506, (01)04056869006703(21)145528, (01)04056869006703(21)145547, (01)04056869006703(21)46206, (01)04056869006703(21)145552, (01)04056869006703(21)45129, (01)04056869006703(21)145330, (01)04056869006703(21)45910, (01)04056869006703(21)145128, (01)04056869006703(21)145750, (01)04056869006703(21)45976, (01)04056869006703(21)145688, (01)04056869006703(21)45182, (01)04056869006703(21)145497, (01)04056869006703(21)45411, (01)04056869006703(21)145150, (01)04056869006703(21)45213, (01)04056869006703(21)145115, (01)04056869006703(21)45683, (01)04056869006703(21)145672, (01)04056869006703(21)145526, (01)04056869006703(21)45737, (01)04056869006703(21)45753, (01)04056869006703(21)145041, (01)04056869006703(21)145042, (01)04056869006703(21)45339, (01)04056869006703(21)45338, (01)04056869006703(21)145040, (01)04056869006703(21)145167, (01)04056869006703(21)45403, (01)04056869006703(21)145799, (01)04056869006703(21)14
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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