Siemens Healthineers issues correction for MRI systems affected by recent Class 1 recall
Siemens Healthineers has issued a correction for its 3T MRI systems that were recently the subject of a Class 1 recall.
Siemens first alerted customers about safety issues with nine different scanners from its Magnetom series of MRI offerings in August. Authorities said there have been problems with the systems’ ventilation, which could be subject to pressure buildup of helium in the event of a quench—rapid loss of superconductivity in the machine's magnet. Such a buildup could cause the helium containment system to rupture and leak helium into the scanning room or potentially trigger an explosion. The issue was categorized as a Class 1 recall due to its potential to cause serious bodily harm or death.
The U.S. Food and Drug Administration announced the recall in early October. Now, Siemens is issuing an official device correction with more detailed information to assist operators in the event of a system error that could trigger the issue.
If operators encounter the error message “Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Healthineers Service,” they will no longer be able to complete scans. In these instances, they should closely adhere to the following instructions:
When the message appears, do not reboot the system.
Remove the patient from the scanner.
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.
Additionally, Siemens cautioned users not to initiate a manual quench unless there is an emergency. The company also recommended staff ensure all exits from the scanning room are unobstructed at all times, and to grant access to the system so a Siemens Healthineers representative can conduct an inspection. If the error message has not occurred, the system can be used until an inspection has been completed.
So far, there have not been any reported deaths nor injuries related to the issue.
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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.