FDA (Devices) recall action 79766
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
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 two Oncor Expression linear accelerators to update software and reduce the risk of collision during automated cancer treatments.
Siemens is recalling one Oncor Avant-garde linear accelerator to update software and reduce the risk of collision during automated cancer treatments.
Siemens is recalling 15 Oncor Impression Plus linear accelerators to update software and reduce the risk of collision during automated cancer treatments.
Siemens is recalling 18 PRIMUS HI Digital Linear Accelerators to update software and reduce the risk of collision during automated cancer treatments.
Siemens is recalling 18 MEVATRON M2 linear accelerators to update software and reduce the risk of collision during automated cancer treatments.
Siemens is recalling seven ONCOR Impression Digital Linear Accelerators to update software and reduce the risk of collision during automated cancer treatments.