Hundreds of MRI units affected by FDA Class 1 recall

The U.S. Food and Drug Administration has announced a recall impacting several types of Siemens Healthineers MRI systems. 

The action relates to nine different scanners from the Magnetom series of magnetic resonance imaging offerings, with hundreds such units in use across the globe. Authorities said there have been problems with the systems’ ventilation, which could be subject to pressure buildup in the event of a quench—rapid loss of superconductivity in the machine's magnet. This is categorized as a Class 1 recall, the FDA's most serious designation, suggesting failure to address these issues could "cause serious adverse health consequences or death." 

"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,” the recall notice reads. “This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.” 

Siemens Healthineers alerted users about the safety issue via letter on Aug. 28. The message informed customers that a qualified representative would be sent to inspect each system and, if necessary, take corrective action to fix the issue. Radiology providers also were instructed to post the safety advisory notice they received in an area where all operators will be aware of the glitch. Additionally, imagers must avoid trying to reboot their Magnetom systems.

Siemens Healthineers is currently investigating the issue; those who have questions or concerns about their systems can contact Rebecca Tudor at 610-219-4834. 

Learn more about the recall here.