FDAFDA · Food and drugs·Recall number Z-1901-2019
Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
Published July 10, 2019 · Recall initiated: June 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide
- Lot
- Serial Numbers: 117309 117125
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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