Siemens Medical Solutions USA, Inc medical device recall: Biograph mMR. Model Number: 10433372

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.

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Aug 28, 2025. FDA classified it 33 days later, on Sep 30, 2025. This recall event covers 15 separate products, each with its own FDA recall number. Distribution reported by FDA: 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… Siemens Medical Solutions USA, Inc has 400 recalls in our records.

Recalled products (15)

• Z-2654-2025 Class I Ongoing

  Biograph mMR. Model Number: 10433372.

  Codes / lots: Model Number: 10433372. UDI Number: (01)04056869006741(21)151032, (01)04056869006741(21)151057, (01)04056869006741(21)510535, (01)04056869006741(21)151034, (01)04056869006741(21)51003, (01)04056869006741(21)151021, (01)04056869006741(21)51055, (01)04056869006741(21)151013, (01)04056869006741(21)51064, (01)04056869006741(21)151044, (01)04056869006741(21)51038, (01)04056869245188(21)51006, (01)04056869006741(21)51030, (01)04056869006741(21)151004, (01)04056869006741(21)51022, (01)04056869006741(21)151049, (01)04056869006741(21)51007, (01)04056869006741(21)151045, (01)04056869006741(21)51032, (01)04056869006741(21)51057, (01)04056869006741(21)51015, (01)04056869006741(21)151025, (01)04056869006741(21)51048, (01)04056869006741(21)51062, (01)04056869006741(21)51010, (01)04056869006741(21)51051. Serial Numbers: 151032, 151057, 51053, 151034, 51003, 151021, 51055, 151013, 51064, 151044, 51038,…

  Quantity: 27 units

• Z-2655-2025 Class I Ongoing

  BIOGRAPH One (DE). Model Number: 11689172.

  Codes / lots: Model Number: 11689172. UDI Numbers: (01)4068151020472(21)238008. Serial Number: 238008.

  Quantity: 1 unit

• Z-2656-2025 Class I Ongoing

  MAGNETOM Cima.X (DE). Model Number: 11647158.

  Codes / lots: Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213029, (01)04056869975221(21)213006, (01)04056869975221(21)213062, (01)04056869975221(21)213043, (01)04056869975221(21)213041, (01)04056869975221(21)213034, (01)04056869975221(21)213035, (01)04056869975221(21)213028, (01)04056869975221(21)213031, (01)04056869975221(21)213018, (01)04056869975221(21)213061, (01)04056869975221(21)213005, (01)04056869975221(21)213021, (01)04056869975221(21)213022, (01)04056869975221(21)213056, (01)04056869975221(21)213030, (01)04056869975221(21)213039, (01)04056869975221(21)213025, (01)04056869975221(21)213063, (01)04056869975221(21)213057, (01)04056869975221(21)213026, (01)04056869975221(21)213020. Serial Numbers: 213029, 213006, 213062, 213043, 213041, 213034, 213035, 213028, 213031, 213018, 213061, 213005, 213021, 213022, 213056, 213030, 213039, 213025, 213063, 213057, 213026, 213020.

  Quantity: 22 units

• Z-2657-2025 Class I Ongoing

  MAGNETOM Connectom.X. Model Number: 11371480.

  Codes / lots: Model Number: 11371480. UDI Numbers: N/A. Serial Numbers: 237551.

  Quantity: 1 unit

• Z-2658-2025 Class I Ongoing

  MAGNETOM Lumina (DE). Model Number: 11344916.

  Codes / lots: Model Number: 11344916. UDI Numbers: (01)04056869230740(21)196458, (01)04056869230740(21)196591, (01)04056869230740(21)196655, (01)04056869230740(21)196355, (01)04056869230740(21)196733, (01)04056869230740(21)196668, (01)04056869230740(21)196477, (01)04056869230740(21)196343, (01)04056869230740(21)196553, (01)04056869230740(21)196519, (01)04056869230740(21)196366, (01)04056869230740(21)196782, (01)04056869230740(21)196617, (01)04056869230740(21)196684, (01)04056869230740(21)196502, (01)04056869230740(21)196539, (01)04056869230740(21)196280, (01)04056869230740(21)196626, (01)04056869230740(21)196511, (01)04056869230740(21)196643, (01)04056869230740(21)196796, (01)04056869230740(21)196551, (01)04056869230740(21)196495, (01)04056869230740(21)196741, (01)04056869230740(21)196621, (01)04056869230740(21)196611, (01)04056869230740(21)196544, (01)04056869230740(21)196724,…

  Quantity: 130 units

• Z-2659-2025 Class I Ongoing

  MAGNETOM Prisma. Model Number: 10849582.

  Codes / lots: Model Number: 10849582. UDI Numbers: (01)04056869006727(21)166324, (01)04056869006727(21)66104, (01)04056869006727(21)166097, (01)04056869006727(21)166024, (01)04056869006727(21)166018, (01)04056869006727(21)66109, (01)04056869006727(21)66111, (01)04056869006727(21)166114, (01)04056869006727(21)166242, (01)04056869006727(21)166268, (01)04056869006727(21)166200, (01)04056869006727(21)166047, (01)04056869006727(21)66047, (01)04056869006727(21)166292, (01)04056869006727(21)166041, (01)04056869006727(21)166007, (01)04056869006727(21)166037, (01)04056869006727(21)66112, (01)04056869006727(21)166025, (01)04056869006727(21)166003, (01)04056869006727(21)66102, (01)04056869006727(21)166254, (01)04056869006727(21)166074, (01)04056869006727(21)166281, (01)04056869006727(21)166220, (01)04056869006727(21)66027, (01)04056869006727(21)166221, (01)04056869006727(21)166321, (01)04056869006727(21)166193,…

  Quantity: 101 units

• Z-2660-2025 Class I Ongoing

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

  Codes / lots: 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,…

  Quantity: 586 units

• Z-2661-2025 Class I Ongoing

  MAGNETOM Skyra fit. Model Number: 10849580.

  Codes / lots: 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,…

  Quantity: 56 units

• Z-2662-2025 Class I Ongoing

  MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

  Codes / lots: Model Number: 11516217. UDI Numbers: (01)04056869299273(21)212087, (01)04056869299273(21)212098, (01)04056869299273(21)212088, (01)04056869299273(21)212068, (01)04056869299273(21)212081, (01)04056869299273(21)212018, (01)04056869299273(21)212041, (01)04056869299273(21)212038, (01)04056869299273(21)212047, (01)04056869299273(21)212019, (01)04056869299273(21)212037, (01)04056869299273(21)212032, (01)04056869299273(21)212049, (01)04056869299273(21)212017, (01)04056869299273(21)212064, (01)04056869299273(21)212096, (01)04056869299273(21)212065, (01)04056869299273(21)212016, (01)04056869299273(21)212023, (01)04056869299273(21)212056, (01)04056869299273(21)212054, (01)04056869299273(21)212063, (01)04056869299273(21)212051, (01)04056869299273(21)212055, (01)04056869299273(21)212021, (01)04056869299273(21)212060, (01)04056869299273(21)212011, (01)04056869299273(21)212066,…

  Quantity: 39 units

• Z-2663-2025 Class I Ongoing

  MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.

  Codes / lots: 1. Model Number: 10837643. UDI Number: (01)04056869006802(21)72030. Serial Number: 72030. Additional serial number added 11/14/2025: 72023. 2. Model Number: 10655588. UDI Number: (01)04056869006796(21)56069. Serial Number: 56069.

  Quantity: 3 units

• Z-2664-2025 Class I Ongoing

  MAGNETOM Verio. Model Number: 10276755.

  Codes / lots: 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,…

  Quantity: 154 units

• Z-2665-2025 Class I Ongoing

  MAGNETOM Verio Dot. Model Number: 10684333.

  Codes / lots: Model Number: 10684333. UDI Numbers: (01)04056869006673(21)60060, (01)04056869006673(21)160040, (01)04056869006673(21)160028, (01)04056869006673(21)160021, (01)04056869006673(21)60108, (01)04056869006673(21)60121, (01)04056869006673(21)160019, (01)04056869006673(21)60091, (01)04056869006673(21)160020, (01)04056869006673(21)160043, (01)04056869006673(21)60062, (01)04056869006673(21)60061, (01)04056869006673(21)160029, (01)04056869006673(21)160038, (01)04056869006673(21)60086, (01)04056869006673(21)60126, (01)04056869006673(21)60047, (01)04056869006673(21)160036, (01)04056869006673(21)160003, (01)04056869006673(21)160042, (01)04056869006673(21)160024, (01)04056869006673(21)60092, (01)04056869006673(21)160035, (01)04056869006673(21)60102, (01)04056869006673(21)160039, (01)04056869006673(21)60112, (01)04056869006673(21)160030, (01)04056869006673(21)60099, (01)04056869006673(21)160007,…

  Quantity: 59 units

• Z-2666-2025 Class I Ongoing

  MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

  Codes / lots: Model Number: 10684334. UDI Numbers: (01)04056869006680(21)162012, (01)04056869006680(21)162055, (01)04056869006680(21)162039, (01)04056869006680(21)162002, (01)04056869006680(21)162014, (01)04056869006680(21)162069, (01)04056869006680(21)162083, (01)04056869006680(21)162075, (01)04056869006680(21)162028, (01)04056869006680(21)162060, (01)04056869006680(21)162035, (01)04056869006680(21)162038, (01)04056869006680(21)162016, (01)04056869006680(21)62040, (01)04056869006680(21)162036, (01)04056869006680(21)162079, (01)04056869006680(21)162054, (01)04056869006680(21)162088, (01)04056869006680(21)162071, (01)04056869006680(21)162078, (01)04056869006680(21)62032, (01)04056869006680(21)62037, (01)04056869006680(21)162077, (01)04056869006680(21)162042, (01)04056869006680(21)162025, (01)04056869006680(21)162082, (01)04056869006680(21)162085, (01)04056869006680(21)162026,…

  Quantity: 78 units

• Z-2667-2025 Class I Ongoing

  MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

  Codes / lots: Model Number: 11060815. UDI Numbers: (01)04056869039176(21)176636, (01)04056869039176(21)177211, (01)04056869039176(21)175728, (01)04056869039176(21)175685, (01)04056869039176(21)175851, (01)04056869039176(21)175768, (01)04056869039176(21)177298, (01)04056869039176(21)177295, (01)04056869039176(21)176756, (01)04056869039176(21)175754, (01)04056869039176(21)177349, (01)04056869039176(21)176757, (01)04056869039176(21)177232, (01)04056869039176(21)175935, (01)04056869039176(21)176967, (01)04056869039176(21)175741, (01)04056869039176(21)177052, (01)04056869039176(21)176060, (01)04056869039176(21)176371, (01)04056869039176(21)177012, (01)04056869039176(21)177146, (01)04056869039176(21)175770, (01)04056869039176(21)176375, (01)04056869039176(21)176122, (01)04056869039176(21)176308, (01)04056869039176(21)175669, (01)04056869039176(21)176212, (01)04056869039176(21)176755,…

  Quantity: 498 units

• Z-2668-2025 Class I Ongoing

  MAGNETOM Vida Fit. Model Number: 11410481.

  Codes / lots: Model Number: 11410481. UDI Numbers: (01)04056869245188(21)202129, (01)04056869245188(21)202025, (01)04056869245188(21)202139, (01)04056869245188(21)202016, (01)04056869245188(21)202051, (01)04056869245188(21)202055, (01)04056869245188(21)202114, (01)04056869245188(21)202119, (01)04056869245188(21)202013, (01)04056869245188(21)202050, (01)04056869245188(21)202102, (01)04056869245188(21)202160, (01)04056869245188(21)202127, (01)04056869245188(21)202071, (01)04056869245188(21)202078, (01)04056869245188(21)202123, (01)04056869245188(21)202082, (01)04056869245188(21)202107, (01)04056869245188(21)202031, (01)04056869245188(21)202110, (01)04056869245188(21)202108, (01)04056869245188(21)202101, (01)04056869245188(21)202093, (01)04056869245188(21)202104, (01)04056869245188(21)202028, (01)04056869245188(21)202026, (01)04056869245188(21)202076, (01)04056869245188(21)202142,…

  Quantity: 41 units