There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. 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.
Reason for recall: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. 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. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China. Quantity: N/A Lot/code info: IMRIS Part Number(s): 120823-000, UDI/DI 00857534006745
00857534006745
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.