FDA (Devices) recall action 97530
The FDA (Devices) publishes a recall like this one as 15 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 15 pages.
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, 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.
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.
Siemens is recalling 56 MAGNETOM Skyra fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling 22 MAGNETOM Cima.X (DE) systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Siemens is recalling 59 MAGNETOM Verio Dot systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling 41 MAGNETOM Vida Fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling 101 MAGNETOM Prisma MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Siemens is recalling 498 MAGNETOM Vida (DE) MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling 586 MAGNETOM Skyra (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Siemens is recalling three MAGNETOM Spectra MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Siemens is recalling 78 MAGNETOM Verio Dot Upgrade systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling one BIOGRAPH One (DE) system because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Siemens is recalling 27 Biograph mMR systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
A MAGNETOM Connectom.X MRI system is being recalled because an ice blockage in the magnet venting system could prevent helium from escaping during a quench.
Siemens is recalling 154 MAGNETOM Verio MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.
Siemens is recalling 130 MAGNETOM Lumina (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.
Siemens is recalling 39 MAGNETOM Skyra Fit BioMatrix systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.