Siemens Healthineers recalls Uroskop Omnia Max model 10762473 due to software issues causing system collisions and incorrect diagnoses. Affected units have specific serial numbers listed.
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 the Uroskop Omnia Max model 10762473 because two software issues could cause the system to collide with obstacles or people during operation, or lead to incorrect diagnostic images. This recall affects medical imaging devices used for visualizing anatomical structures.
The software issues can cause the system to collide with obstacles or people when the override function is used during blocked system movements. Additionally, incorrectly assigned images may lead to incorrect diagnostic results for certain systems, potentially affecting patient care.
Medical professionals who use the Uroskop Omnia Max system for X-ray imaging are most at risk. The recall applies to specific units with serial numbers listed in the official notice.
Check if your Uroskop Omnia Max system has the model number 10762473 and one of the listed serial numbers (4557, 4574, 4571, etc.). The product is used for visualizing anatomical structures via X-ray imaging.
Verify if your device has a serial number from the list provided in the recall notice.
The recall is due to two software issues: one that could cause the system to collide with obstacles or people during operation, and another that may lead to incorrect diagnostic images.
The Uroskop Omnia Max model 10762473 with specific serial numbers listed in the recall notice.
No, but you should check if your device is affected and follow the action steps to ensure safety.
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-2757-2020 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-2757-2020 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.
