medical Class II Updated 2019-07-10

Siemens Medical Solutions USA, Inc recalls Siemens Artis zee floor -Interventional Fluoroscopic X-Ray S

Recalled Product

Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 135954 136032 136077 136043 136190 136197 136168 136143 136234 136383 136242 136393 136128 136147 136350 136256 136314 136548 136550 136557 136558 137165 137119 136607 137388 137231 137471 137591 137245 137369 137347 137329 137391 137479 137425 124006 138061 137461 137518 137567 137582 137667 137595 137656 138104 138190 124116 137714 124119 138012 138070 138017 138058 138194 138156 138214 138128 138180 138188 138260 138268 138311 138259
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