FDA (Devices) recall action 83082
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
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 eight Artis fluoroscopic X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury.
Siemens is recalling 63 Artis zee X-ray systems because ceiling support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 29 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 120 Artis X-Ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 12 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 11 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 276 Artis zee ceiling-mounted X-ray systems because screws joining the pivot bearing to the ceiling support may work loose or snap off, posing a risk of severe injury.
Siemens is recalling two Artis Q zeego X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 131 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling eight Artis X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury to patients and staff.
Siemens is recalling 73 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury.
Siemens is recalling 15 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.