Siemens Medical Solutions USA, Inc recalls MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number:…

Recall date

August 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2663-2025

FDA classification

Class I

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

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, Cy…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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