MAGNETOM Verio. Model Number: 10276755.
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: 10276755. UDI Numbers: N/A. Serial Numbers: 40649, 40585, 40781, 40243, 40408, 40628, 40848, 40870, 40783, 40473, 40240, 40497, 40564, 40425, 40778, 40389, 40340, 40523, 40582, 40168, 40291, 40283, 40201, 40850, 40331, 40126, 40744, 40821, 40433, 40502, 40179, 40246, 40273, 40766, 40753, 40828, 40737, 40352, 40313, 40382, 40670, 40387, 40631, 40669, 40131, 40541, 40466, 40292, 40375, 40161, 40745, 40268, 40284, 40325, 40799, 40190, 40877, 40104, 40195, 40407, 40640, 40797, 40254, 40142, 40665, 40622, 40264, 40420, 40633, 40150, 40514, 40727, 40710, 40328, 40156, 40800, 40692, 40165, 40441, 40864, 40482, 40472, 40859, 40220, 40858, 40779, 40346, 40295, 40233, 40629, 40681, 40464, 40568, 40200, 40663, 40334, 40277, 40276, 40879, 40222, 40361, 40553, 40378, 40714, 40715, 40252, 40250, 40423, 40204, 40486, 40251, 40488, 40109, 40855, 40429, 40232, 40157, 40440, 40259, 40545, 40556, 40687, 40140, 40237, 40399, 40312, 40235, 40697, 40684, 40398, 40871, 40700, 40368, 40656, 40606, 40163, 40278, 40562, 40671, 40526, 40658, 40644, 40376, 40686, 40713, 40775, 40863, 40326, 40409, 40116. Additional serial number added 11/14/2025: 40250. Additional serial number added 01/21/2026: 40459. Additional serial number added 2/25/2026: 40464. Additional serial number added 4/17/2026: 40711;
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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