The FDA is amplifying a recall effort underway at Siemens Healthineers related to several of its MRI machines, linked to their helium containment and the potential for a dangerous rupture.
The company began notifying operators and healthcare providers in late August about the possibility of ice buildups within the supercooled magnet’s venting systems.
This ice can form blockages that—in the event of an emergency shutdown known as a quench, where liquid helium is rapidly boiled off into a gas—could cause pressure to spike and ultimately leak helium into the scanning room, raising the risks of suffocation.
The issue spans more than a dozen of Siemens Healthineers’ internationally distributed models, including across its Magnetom family and its line of Biograph combination MR/PET scanners. This week, the FDA handed down a Class I recall designation to the problem, its most serious.
According to the agency, the root causes are still under investigation. Siemens Healthineers and its customer service organizations have said they are preparing to conduct inspections of the affected units and will perform fixes if necessary.
The company cautioned users to not reboot their systems if they discover any issues, but to call their local service provider. Siemens Healthineers also recommends preventive magnet maintenance for ice buildups that can cause thermal instability and trigger a quench.
Fellow imaging giant Philips previously received a similar Class I recall label from the FDA in 2023, related to its Panorama 1.0T open MRI, where a blocked quench could potentially lead to helium pressure strong enough to cause an explosion within the scanner itself.