Siemens Healthineers recalls Luminos Agile Max Model 10762472 due to two software issues that could cause system collisions with obstacles or persons, or incorrect diagnostic images affecting patient safety.
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 Luminos Agile Max Model 10762472 because two software issues could cause the system to collide with people or obstacles, or produce incorrect diagnostic images. This poses a risk of inaccurate medical diagnoses and potential safety hazards during use.
The first issue involves the system's override function potentially causing collisions with people or obstacles when movements are blocked. The second issue involves incorrectly assigned images leading to wrong diagnostic bases, which could result in inaccurate medical conclusions.
Medical professionals using the Luminos Agile Max system for X-ray imaging are most at risk. Patients using this system for diagnostic imaging may also be affected if the software issues cause incorrect images.
This product is identified by the model number 10762472 and serial numbers listed in the recall notice. It is used for X-ray imaging to visualize anatomical structures.
Ensure the system has the latest software updates to address the known issues.
The model number is 10762472.
Two software issues: (1) The override function may cause collisions with obstacles or persons when system movements are blocked, and (2) Incorrectly assigned images may lead to wrong diagnostic bases.
Check if your device has the model number 10762472 and one of the listed serial numbers in the recall notice.
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-2756-2020 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-2756-2020 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.
