FDA (Devices) recall action 97920
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
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 one MAMMOMAT Fusion system because an operator table was sold together with a bus-installation kit it is not released for.
Siemens Medical Solutions USA is recalling 7 MAMMOMAT Revelation systems because operator tables were sold together with a bus-installation kit they are not released for.
Siemens Medical Solutions USA is recalling 6 MAMMOMAT Inspiration systems because operator tables were sold together with a bus-installation kit they are not released for.