FDA (Devices) recall action 83415
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
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 Medical Solutions USA is recalling 143 MAGNETOM Aera MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.
Siemens Medical Solutions is recalling two MAGNETOM Spectra MRI devices due to a potential open port in the quench venting system.
Siemens is recalling 17 MAGNETOM Prisma MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.
Siemens is recalling 44 MAGNETOM Skyra MRI devices due to a potential open port in the quench venting system when using an optional horizontal outlet.