The FDA has issued a Class I device recall for several Magnetom Vida MRI scanners from Siemens, according to a Sept. 30 notice.
“There is a potential for an ice blockage to form or currently exist within the magnet venting system,” the notice said. The blockage may prevent helium gas from escaping, resulting in a pressure build-up and eventual rupture of the helium containment system.
Siemens notified customers of the issue on or around Aug. 28 and is preparing to conduct system inspections and perform corrections if necessary.
Affected Magnetom Vida product and model numbers can be found here.
A Class I recall is issued when there is “reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
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