Home / Recalls / Siemens Medical Solutions USA, Inc / Z-2659-2025

Z-2659-2025 Class I Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

Recall Details

Product Type: Devices
Report Date: October 8, 2025
Initiation Date: August 28, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 101 units

Product Description

MAGNETOM Prisma. Model Number: 10849582.

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.

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.

Code Information

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, (01)04056869006727(21)166012, (01)04056869006727(21)166121, (01)04056869006727(21)66053, (01)04056869006727(21)166160, (01)04056869006727(21)66094, (01)04056869006727(21)166310, (01)04056869006727(21)66028, (01)04056869006727(21)166102, (01)04056869006727(21)166034, (01)04056869006727(21)166030, (01)04056869006727(21)66106, (01)04056869006727(21)166235, (01)04056869006727(21)166273, (01)04056869006727(21)166201, (01)04056869006727(21)166345, (01)04056869006727(21)166225, (01)04056869006727(21)66044, (01)04056869006727(21)66018, (01)04056869006727(21)166006, (01)04056869006727(21)166009, (01)04056869006727(21)166295, (01)04056869006727(21)166227, (01)04056869006727(21)166188, (01)04056869006727(21)166046, (01)04056869006727(21)166296, (01)04056869006727(21)166298, (01)04056869006727(21)66022, (01)04056869006727(21)66057, (01)04056869006727(21)166326, (01)04056869006727(21)166327, (01)04056869006727(21)166048, (01)04056869006727(21)166289, (01)04056869006727(21)166049, (01)04056869006727(21)66069, (01)04056869006727(21)166040, (01)04056869006727(21)166039, (01)04056869006727(21)166017, (01)04056869006727(21)66092, (01)04056869006727(21)66105, (01)04056869006727(21)166224, (01)04056869006727(21)166319, (01)04056869006727(21)166014, (01)04056869006727(21)166239, (01)04056869006727(21)66046, (01)04056869006727(21)66082, (01)04056869006727(21)166362, (01)04056869006727(21)166179, (01)04056869006727(21)166019, (01)04056869006727(21)166311, (01)04056869006727(21)166330, (01)04056869006727(21)166133, (01)04056869006727(21)166210, (01)04056869006727(21)166285, (01)04056869006727(21)166162, (01)04056869006727(21)66096, (01)04056869006727(21)166082, (01)04056869006727(21)166083, (01)04056869006727(21)66059, (01)04056869006727(21)166084, (01)04056869006727(21)166250, (01)04056869006727(21)166023, (01)04056869006727(21)166272, (01)04056869006727(21)166090, (01)04056869006727(21)166038, (01)04056869006727(21)166158, (01)04056869006727(21)166315, (01)04056869006727(21)166091, (01)04056869006727(21)166313, (01)04056869006727(21)166307, (01)04056869006727(21)166033, (01)04056869006727(21)166010, (01)04056869006727(21)166011. Serial Numbers: 166324, 66104, 166097, 166024, 166018, 66109, 66111, 166114, 166242, 166268, 166200, 166047, 66047, 166292, 166041, 166007, 166037, 66112, 166025, 166003, 66102, 166254, 166074, 166281, 166220, 66027, 166221, 166321, 166193, 166012, 166121, 66053, 166160, 66094, 166310, 66028, 166102, 166034, 166030, 66106, 166235, 166273, 166201, 166345, 166225, 66044, 66018, 166006, 166009, 166295, 166227, 166188, 166046, 166296, 166298, 66022, 66057, 166326, 166327, 166048, 166289, 166049, 66069, 166040, 166039, 166017, 66092, 66105, 166224, 166319, 166014, 166239, 66046, 66082, 166362, 166179, 166019, 166311, 166330, 166133, 166210, 166285, 166162, 66096, 166082, 166083, 66059, 166084, 166250, 166023, 166272, 166090, 166038, 166158, 166315, 166091, 166313, 166307, 166033, 166010, 166011.