{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215859", "product_res_number": "Z-2660-2025", "event_date_initiated": "2025-08-28", "event_date_posted": "2025-09-30", "recall_status": "Open, Classified", "res_event_number": "97530", "product_code": "LNH", "k_numbers": [ "K101347", "K231560" ], "product_description": "MAGNETOM Skyra (DE). Model Number: 10432915.\n\n510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.", "code_info": "Model Number: 10432915. 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Serial Numbers: 45046, 45115, 45398, 145760, 145811, 45549, 45834, 146099, 146110, 45047, 146093, 46066, 45788, 146082, 45124, 45185, 45332, 45466, 145390, 45732, 45918, 45380, 46182, 45735, 45233, 145735, 145008, 145473, 145095, 145664, 45200, 146098, 146086, 45805, 45812, 45397, 46264, 45499, 45749, 45289, 46220, 45369, 45267, 45253, 45060, 146103, 45333, 146123, 46147, 145721, 145840, 145088, 146124, 45841, 45890, 46295, 45306, 45519, 145905, 46242, 145806, 46171, 45148, 45152, 46194, 145152, 45119, 46207, 145549, 45402, 145090, 145681, 45877, 45693, 45679, 146067, 45140, 46163, 145635, 46028, 45138, 46282, 45479, 45496, 45143, 45314, 45368, 46268, 45998, 145423, 145190, 145377, 46005, 45886, 45905, 145706, 145684, 45990, 145063, 146119, 46260, 45118, 145062, 45506, 145528, 145547, 46206, 145552, 45129, 145330, 45910, 145128, 145750, 45976, 145688, 45182, 145497, 45411, 145150, 45213, 145115, 45683, 145672, 145526, 45737, 45753, 145041, 145042, 45339, 45338, 145040, 145167, 45403, 145799, 145843, 145658, 145086, 45197, 45196, 145108, 46203, 145414, 46027, 145301, 45988, 45279, 145384, 145596, 45881, 145568, 45942, 146085, 145685, 145674, 45088, 145862, 45095, 45676, 46144, 45108, 145300, 46044, 46169, 45537, 145026, 46290, 145758, 45084, 145270, 146117, 146092, 45195, 145631, 45684, 45940, 146114, 145666, 145380, 145816, 45120, 145921, 145842, 145554, 46232, 45135, 145710, 145044, 145686, 46279, 145638, 145367, 145170, 145689, 145187, 45495, 45298, 145164, 46176, 45399, 46261, 145334, 145633, 45375, 45351, 146128, 45276, 46179, 145610, 46048, 145810, 46168, 46121, 45705, 45284, 145669, 145831, 145206, 145667, 45477, 145104, 45112, 146075, 145445, 46032, 145544, 46050, 45212, 46276, 145687, 145099, 145256, 46161, 46020, 45761, 145338, 45736, 145541, 145545, 145259, 145952, 46149, 45149, 45407, 45327, 45944, 45006, 45371, 46238, 145130, 45983, 46189, 145700, 45236, 45201, 145747, 46273, 45520, 145774, 46303, 45116, 145262, 145663, 45456, 45624, 145754, 45599, 145148, 45690, 45963, 45346, 45995, 45293, 145179, 45770, 145161, 145145, 145620, 145476, 46127, 45435, 45155, 46047, 45295, 45160, 45603, 145892, 45543, 45847, 145269, 145770, 46259, 45817, 145827, 45856, 45526, 145731, 145640, 145266, 45117, 45324, 45968, 145775, 45372, 145454, 45249, 45958, 145343, 145255, 145110, 46286, 145609, 145790, 145030, 145011, 145012, 145105, 45219, 145061, 145533, 145532, 45774, 45167, 45069, 146105, 145924, 145113, 45085, 45741, 45147, 145193, 46289, 145622, 45121, 45150, 46175, 45536, 46237, 145032, 46191, 46143, 45733, 46081, 45158, 45110, 145492, 46100, 45379, 45318, 145394, 45681, 145886, 145491, 45425, 145761, 45031, 145632, 145182, 145124, 45996, 45107, 45428, 45635, 46021, 46007, 46105, 46142, 45203, 45018, 145850, 146102, 146100, 45019, 145826, 145521, 145860, 45417, 45928, 145097, 145323, 46205, 145325, 45906, 146115, 45815, 45042, 145594, 145801, 45500, 45986, 45202, 45553, 45381, 145020, 45566, 145990, 145728.45959, 46009, 45134, 145447, 45474, 145149, 45099, 45349, 46150, 145143, 46016, 145605, 146127, 145785, 45623, 145089, 145209, 45835, 145302, 145815, 45082, 45079, 45878, 45452, 145246, 46086, 45850, 46239, 46140, 45773, 145293, 145127, 45556, 45870, 145486, 46026, 145485, 145403, 145624, 145245, 46034, 45455, 145443, 145297, 45288, 145582, 145772, 46297, 45667, 45430, 146090, 45074, 45585, 45128, 45239, 145386, 145489, 45328, 45580, 45122, 45078, 145449, 45387, 45804, 145536, 145569, 145781, 145629, 145504, 45682, 45072, 145565, 46222, 45948, 145718, 145282, 45056, 45970, 45408, 145066, 145796, 46310, 46311, 45273, 45214, 45631, 45386, 145275, 145704, 45406, 46107, 46102, 45080, 145717, 145320, 45220, 45424, 145522, 145230, 45228, 45348, 45649, 46190, 145142, 145636, 145222, 145111, 145598, 45181, 45229, 45105, 145839, 45840, 45685, 145292, 45132, 46288, 45291, 45857, 46157, 45266, 45839, 45208, 146078, 145450, 45307, 45982, 46145, 46298, 145169, 45237, 45869, 45230, 45205, 45694, 45507, 46281, 145311, 45232, 145662, 45390, 145087, 45255, 145332, 45409, 45559, 45130, 146120, 145197, 45777, 145072, 145626, 145794, 145864, 146122, 146121, 45669, 45801, 45436, 45545, 46201, 46080, 45945, 145227, 45093, 46243, 45818, 45071, 45111, 145075, 46294, 45199, 45638. Additional serial numbers added 11/14/2025: 45395, 45442, 45291. Additional serial numbers added 01/23/2026: 45108, 45129. Additional serial numbers added 2/25/2026: 45635, 46150, 145696, 46220, 45425, 45733, 45186, 46268, 45913.", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "city": "Malvern", "state": "PA", "postal_code": "19355-1418", "additional_info_contact": "Rebecca Tudor\n484-323-4198", "reason_for_recall": "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.", "root_cause_description": "Under Investigation by firm", "action": "Siemens Healthcare notified consignees on about 08/28/2025 via letter. Consignees were informed that Siemens Customer Service Organization will conduct an inspection of affected units to address the issue. If customers identify issues, they are cautioned to not reboot the system, to call their local Siemens Healthineers service organization, and grant access to the system. Siemens will inspect devices and perform a correction, if needed. Consignees were also instructed to ensure all users or customers are notified of the issue and to maintain the Customer Safety Advisory Notice. Consignees were also requested to confirm receipt and acknowledgement of the notification.\n\nSiemens expanded the recall and notified consignees on about 10/01/2025 via letter. These notifications included the same information as initially sent to consignees. \n\nA follow up communication was sent to consignees on about 10/15/2025 via letter. This informed users of further details and additional necessary safety actions. If a specific \"Magnent Supervision\" error message appears on the host computer, no further scans can be performed, and you are requested to: not reboot the system, remove the patient from the system, lock/secure all access to the scanning room with the system remaining energized at field, post a DO NOT USE notice on or near the device, and call the Siemens Healthineers service organization. In addition, Siemens reminded users that the Magnet Stop button is only intended for emergencies. DO NOT initiate a manual quench of the magnet unless there is an emergency. Ensure all designated emergency exit routes remain unobstructed and are marked. Consignees were also instructed to ensure all users or customers are notified of the issue, to maintain the Customer Safety Advisory Notice is retained in product related records, to confirm receipt and acknowledgement of the notification, and if the affected system is no longer in the consignee's possession, notify the new owner.\n\n***Updat", "product_quantity": "586 units", "distribution_pattern": "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.", "openfda": { "k_number": [ "K232346", "K883520", "K250443", "K932344", "K121650", "K920441", "K102344", "K213583", "K240157", "K923823", "K081028", "K212367", "K100164", "K914536", "K924472", "K072998", "K240540", "K223426", "K903754", "K905512", "K160618", "K210415", "K173409", "K935084", "K962677", "K954646", "K033504", "K241496", "K895328", "K080968", "K193200", 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