Siemens Medical Solutions USA, Inc Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Numbers: 123049 123216 123046 123236 123211 123202 123043 123219 123240 123230 123246
Products Sold
Serial Numbers: 123049 123216 123046 123236 123211 123202 123043 123219 123240 123230 123246
Siemens Medical Solutions USA, Inc is recalling Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355 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