FDA-Device2019-07-10Class II
Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Siemens Medical Solutions USA, Inc
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
Sold states
Nationwide
Affected count
8
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1902-2019Don't want to check this manually?
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