The issue affects certain systems in which ice may obstruct the venting system, potentially leading to dangerous overpressure events if a magnet quench occurs.
Siemens Healthineers is correcting 3 Tesla MRI systems due to the potential for an ice blockage to form or currently exist within the magnet venting system, according to a US Food and Drug Administration (FDA) recall alert.
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, the alert notes. This pressure buildup 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 use of affected product may cause serious adverse health consequences, including cold burns, asphyxiation, trauma, and death.
On Aug 27, Siemens Healthineers sent affected customers an Urgent Medical Device Correction letter recommending the following actions:
- 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, 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.
- Be aware that the magnet stop is only intended for emergencies. Do not initiate a manual quench of the magnet unless there is an emergency.
- Ensure all designated emergency exit routes remain unobstructed at all times and are properly marked. In particular, the exit from the examination room must be maintained at all times.
- Grant access to the system so an inspection can be carried out as directed by Siemens Healthineers service organization.
- Make sure all users of affected products and others who may need to be informed receive the relevant safety information provided within the notice and comply with its recommendations.
- If the equipment is no longer at the facility, forward the notice to the equipment’s new owner.
- You may continue to use the system until an inspection has been performed.
As of Aug 29, Siemens Healthineers has not reported any serious injuries or deaths related to this issue.
A list of affected devices can be found on the FDA’s website.
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