Siemens recalls Artis pheno-Interventional Fluoroscopic X-Ray Systems with model 10849000 and specific serial numbers due to risk of screws loosening or snapping, potentially causing severe injuries during procedures.
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 certain Artis pheno-Interventional Fluoroscopic X-Ray Systems because screws connecting the pivot bearing to the ceiling support could loosen or snap, risking severe injuries to patients and staff. This is a serious hazard that requires immediate attention to prevent potential harm.
The system's screws that connect the pivot bearing to the ceiling support can work loose or snap off during use. This could cause the equipment to move unexpectedly, leading to severe injuries for patients and medical staff in the operating room.
Medical facilities using the recalled Siemens Artis systems with model number 10849000 and specific serial numbers are most at risk. Patients and operating personnel during procedures could be harmed if the screws become loose or snap.
Check for model number 10849000 on the system. The specific serial numbers listed include 164021, 164053, 164055, 164054, 164088, 164140, 164113, and 164069. These systems were sold between 2018 and 2020.
Immediately cease using the recalled Siemens Artis pheno-Interventional Fluoroscopic X-Ray System with model number 10849000 and the listed serial numbers.
The affected model number is 10849000.
The affected serial numbers are 164021, 164053, 164055, 164054, 164088, 164140, 164113, and 164069.
These systems were sold between 2018 and 2020.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1905-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1905-2019 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.
