Siemens recalls Artis Q.zen floor-based interventional fluoroscopy systems with specific model numbers due to potential screw failure causing severe injuries during use.
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
Siemens is recalling Artis Q.zen floor-based interventional fluoroscopy systems with model number 10848353. The recall is because screws connecting the system to ceiling supports could loosen or snap, risking serious injury to patients or staff during procedures.
Screws that join the pivot bearing to ceiling-mounted supports can become loose or snap during use. This could cause the system to malfunction, potentially leading to falls or injuries for patients and medical personnel.
Healthcare facilities using the specific model number 10848353 systems are affected. Medical staff and patients during procedures are at highest risk due to potential for severe injury.
Check for model number 10848353 on the system. Serial numbers 105018, 105016, 105032, 105124, 105119, 105123, 105121, and 105122 are also included in this recall.
Immediately cease using the recalled Siemens Artis Q.zen floor-based interventional fluoroscopy system with model number 10848353 or the listed serial numbers.
Model number 10848353 and serial numbers 105018, 105016, 105032, 105124, 105119, 105123, 105121, and 105122.
The recall is due to the potential for screws connecting the system to ceiling supports to loosen or snap, which could cause severe injuries during medical procedures.
Immediately stop using the system and contact Siemens for further instructions.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1902-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1902-2019 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
