Siemens Healthineers recalls Luminos dRF Max model 10762471 due to software issues that may cause system collisions with obstacles or incorrect diagnostic images. Affected units have specific serial numbers listed in the recall.
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 Luminos dRF Max model 10762471 because two software issues could cause the system to collide with people or objects during operation, or produce incorrect diagnostic images. This affects medical imaging devices used in hospitals and clinics.
The first software issue allows the system to collide with obstacles or people when the override function is used during blocked movements. The second issue causes incorrect diagnostic images due to a detector setting that affects Ysio Max, Luminos dRF Max, and Luminos Agile Max systems.
Healthcare facilities using the Luminos dRF Max model 10762471 for medical imaging are most at risk. Patients and staff could be affected if the system malfunctions during procedures.
Check if your device has the model number 10762471 and serial numbers listed in the recall (e.g., 5043, 5085, 5825, etc.). The product is used for medical imaging to visualize anatomical structures.
Verify your device has the model number 10762471 and one of the listed serial numbers.
Two software issues: (1) Using the override function during blocked system movements may cause collisions with obstacles or people, and (2) Incorrectly assigned image settings may cause incorrect diagnostic images.
No, but you should check your device model and serial numbers to see if it is affected. The recall does not require immediate discontinuation.
The recall does not specify a remedy, so contact Siemens Healthineers directly for further instructions.
We’ve drafted a message you can send Siemens Healthineers to request your refund or repair — edit it as you like.
Subject: Recall Z-2755-2020 — Siemens Healthineers Siemens Healthineers Hello, I own a Siemens Healthineers that is covered by recall Z-2755-2020 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.
