Siemens Medical Solutions USA, Inc Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Numbers: 105018 105016 105032 105124 105119 105123 105121 105122
Products Sold
Serial Numbers: 105018 105016 105032 105124 105119 105123 105121 105122
Siemens Medical Solutions USA, Inc is recalling Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Siemens issued letter dated 6/6/19 advising of the problem, health risk and action to take: .Siemens is implementing a corrective action to all potentially affected users via Update Instruction AX023/18/S. Siemens Service organization will replace the screwed connection of the ceiling support according to specifications / instructions. In the event the bolt connection cannot be replaced due to technical conditions, the complete bearing will be replaced.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026