The FDA said that Siemens Healthineers has sent all its affected customers an Urgent Medical Device Correction letter for 3 Tesla Siemens Healthineers MRI systems due to the potential for an ice blockage to form or currently exist within the magnet venting system.
"In the event of a sudden loss of superconductivity, or magnet quench, helium gas may be unable to escape through designated venting paths, leading to pressure build-up within the helium containment system. This pressure build-up could rupture the helium containment system, potentially resulting in a massive helium leak into the scanning room. Rupture of the helium containment system may also manifest as an explosion, with overpressure in the MRI room and debris expelled forcefully," the FDA wrote.
The agency warned that using any affected product may cause cold burns, asphyxiation, trauma, and death.
The FDA is warning medical professionals that if the error message “Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Healthineers Service” appears on the host computer, they need to take the following safety actions:
- Do not reboot the system
- Remove the patient from the system
- Lock/secure all access to the scanning room with the system remaining energized at field
- Post a “DO NOT USE” notice on or near the device
- Call the facility’s local Siemens Healthineers service organization
- Make sure all relevant personnel are aware of this issue
As of August 29, Siemens Healthineers has not reported any serious injuries or deaths related to this issue.
A full list of the affected devices is available here.
