Siemens Medical Solutions USA, Inc: Medical Device Recall in 2025 - (Recall #: Z-2656-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: August 28, 2025

Date Posted: October 8, 2025

Recall Number: Z-2656-2025

Event ID: 97530

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.

Status: Ongoing

Product Quantity: 22 units

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated