by
Gus Iversen, Editor in Chief | October 01, 2025
MAGNETOM Vida MR units are among the recalled scanner models
Siemens Healthineers has issued a Class I recall for several of its 3T MR and PET/MR scanners due to a potentially serious safety issue with the magnet venting system.
The company notified affected facilities via letter on August 28 and the FDA
issued its own notification on September 30.
According to the FDA, the affected systems may experience ice blockages within the magnet venting system. This blockage could prevent helium gas from escaping during a quench event, an emergency shutdown scenario where helium is rapidly expelled to prevent overheating. If venting is obstructed, pressure could build within the helium containment system, leading to a possible rupture and helium leakage into the scanning room.
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The FDA classified the recall as Class I, its most serious category, indicating that use of the device could result in injury or death. A
list of impacted systems provided by the FDA includes over a dozen internationally distributed scanners, including 13 MAGNETOM MR and two BIOGRAPH PET/MR models.
"Siemens Healthineers is aware of a potential safety issue associated with the magnet venting paths of 3 Tesla MR systems at our customer sites," a company spokesperson told HCB News. "An inspection is being carried out by our Customer Service Organization to prevent a possible hazard to patients, operators, other persons or equipment. This proactive measure is part of our obligations and commitment to ensuring continued product performance and customer safety."
Facilities were instructed not to reboot the system if the issue is suspected, to contact local Siemens service teams, and to allow access for inspection. Recipients of the advisory were also asked to inform all relevant personnel of the issue, retain the safety notice in product-related records, and confirm receipt of the communication.
The affected units have been distributed across the U.S., as well as healthcare facilities in Europe, Asia, Africa, and South America.
The root cause of the issue remains under investigation by the manufacturer.
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