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FDAJune 6, 2019device

Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

siemens medical solutionssiemenssiemens medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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