FDA (Devices) recall action 99079
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.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
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 is recalling 119 units of the ARTIS icono ceiling (Model 11328100) due to potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits.
Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.
Siemens Medical Solutions is recalling 30 units of the ARTIS icono floor (Model 11327700) due to potential loss of detector movement capability when adjusted to maximum or minimum height limits.