Siemens Healthineers recalls Ysio Max Interventional Fluoroscopic X-Ray System model 10762470 due to two software issues that may cause system collisions with obstacles or persons, or incorrect diagnostic images.
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
Siemens Healthineers is recalling a specific model of X-ray system (10762470) because two software problems could cause the system to collide with people or objects during use, or produce incorrect diagnostic images. This affects medical facilities using the device for procedures like angiography.
The system has two software issues: one where using an override function during blocked movements could cause the system to collide with obstacles or people, and another where incorrectly assigned images might lead to wrong diagnostic results for certain procedures.
Medical facilities that use the Siemens Healthineers Ysio Max Interventional Fluoroscopic X-Ray System model 10762470 are most at risk. The recall applies to specific serial numbers listed in the official notice.
Check if your X-ray system has the model number 10762470 and one of the listed serial numbers (24576, 24077, 25409, etc.). The device is used for visualizing anatomical structures during medical procedures.
Verify your system's serial number against the list provided in the recall notice to confirm if it is affected.
The recall is due to two software issues that could cause the system to collide with obstacles or people during use, or produce incorrect diagnostic images.
The affected model is Siemens Healthineers Ysio Max Interventional Fluoroscopic X-Ray System with serial number 10762470.
Check if your system has the model number 10762470 and one of the listed serial numbers (e.g., 24576, 24077, 25409, etc.).
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-2758-2020 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-2758-2020 from Siemens Healthineers. 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.
