There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Reason for recall: There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. Distribution: US distribution to California. International distribution to Australia, Germany, Great Britian. Quantity: 4 system (1 US; 3 OUS) Lot/code info: Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.
04056869975245
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.