Siemens recalls ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model 10849000 due to risk of robotic stand blocking by safety brakes, preventing intended movements during procedures.
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
Siemens is recalling its ARTIS Pheno-Interventional Fluoroscopic X-Ray System (Model 10849000) because the robotic stand might get blocked by its safety brakes. This could prevent the system from moving properly during medical procedures, potentially affecting patient safety.
The robotic stand's safety brakes could block one or more axes, preventing the system from moving as intended. This might cause the system to malfunction during medical procedures, potentially affecting patient safety.
Healthcare facilities using the ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model 10849000 are most at risk. This system is used for medical imaging and interventional procedures on patients, including children and obese patients.
Check for the model number 10849000 on the ARTIS Pheno-Interventional Fluoroscopic X-Ray System. This product is used in medical facilities for imaging and interventional procedures.
Verify if the robotic stand is moving properly during procedures; if it stops unexpectedly, stop use immediately.
The recall indicates a potential risk, so it's recommended to check system status and follow the action steps to ensure safety.
Stop using the system immediately and contact Siemens for further instructions.
Look for the model number 10849000 on the ARTIS Pheno-Interventional Fluoroscopic X-Ray System.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1340-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1340-2020 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.
