FDA (Devices) recall action 98112
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Canon Medical Systems is recalling 22 Vantage Titan 3T MRI systems because ice in the magnet venting system could lead to a helium vessel rupture during a quench.
Philips Medical Systems Nederland is recalling 79 units of the Allura Xper FD20, model 722012, because the drip tray beneath the cooling unit may not have been installed.