FDA (Devices) recall action 79214
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.
The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
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 142 Axiom Artis fluoroscopic foot switches that may fail to release radiation due to external impacts.
Siemens Medical Solutions is recalling wireless foot switches for Artis Q and Q.zen fluoroscopic systems because they may fail to release radiation due to external impacts.
Siemens Medical Solutions is recalling 510 foot switch accessories for Artis zee and Artis zeego x-ray systems because they may fail to release radiation.