MRI recall update: New guidance on issue prompting FDA Class 1 safety warning
Hundreds magnetic resonance imaging systems from Siemens Healthineers have been impacted by a recent Class 1 recall issued by the U.S. Food and Drug Administration.
The recall notice indicates the issue relates to the systems’ venting paths, but certain functions within their operating suite, manufactured by IMRIS Imaging Inc., could trigger an adverse event within the scanner itself. The suite is installed on numerous Siemens’ 3T Magnetom MRI systems, including the Skyra, Verio and Vida models.
“Siemens notified IMRIS that an ice blockage may exist within the magnet venting system,” the notice reads. “In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system, which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.”
Class 1 recalls carry the FDA’s most serious warning, suggesting the issue could lead to serious adverse health consequences, including death, if not resolved. This prompted IMRIS to issue an Urgent Medical Device Correction notice to affected customers at the end of September. That notice offered customers the following guidance on what to do when encountering problems with the operating suite:
"If the error message, ‘Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Service,’ appears, do not reboot the system. Please call your local Siemens Healthineers service organization. Grant access to the system so that the inspection can be carried out as directed by Siemens Healthineers service organization."
Siemens also sent out safety notifications on the issue in late August. A recall of the affected MRI systems themselves was issued in early October.
IMRIS instructed users to share the message with personnel who may be operating the systems. Any questions or concerns can be directed to their customer support team at 866-475-0525 or via e-mail at [email protected].
The affected systems are in operation globally. For more information, click here. Find the full list of affected systems here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.