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Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
The FDA is aware that aware that Siemens Healthineers sent all 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 use of affected product may cause serious adverse health consequences, including cold burns, asphyxiation, trauma, and death.
As of August 29, Siemens Healthineers has not reported any serious injuries or deaths related to this issue.
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact the Siemens Healthineers service organization at 1-800-888-7436.
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