Siemens recalls YS: X.Pree x-ray machines due to incorrect collimation display on user interface, potentially causing improper x-ray coverage. Affected units sold in the US with model 11107464.
For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.
Siemens is recalling its YSIO X.Pree x-ray machines because the user interface shows a wider collimation area than what the system actually uses, which could lead to improper x-ray coverage during exams. This issue does not cause immediate harm but may result in inaccurate imaging if not corrected.
The x-ray machine displays a wider collimation area on the user interface than what the system actually uses during imaging. This discrepancy means the machine might cover a larger area than intended, potentially leading to inaccurate x-ray results. However, the machine still functions correctly and matches the user-defined examination area.
Healthcare facilities using Siemens YSIO X.Pree x-ray machines with model number 11107464 are most at risk. Patients undergoing x-rays with these machines could potentially receive inaccurate imaging due to the collimation error.
Check for the model number 11107464 on the YSIO X.Pree x-ray machine. This recall applies to machines sold in the US with this specific model.
Verify the model number on your YSIO X.Pree x-ray machine to confirm it is 11107464.
The recall does not pose an immediate risk of injury or death. The x-ray machine functions correctly but may produce inaccurate imaging due to a display error.
Check for the model number 11107464 on your YSIO X.Pree x-ray machine. This recall applies to machines sold in the US with this specific model.
The recall does not require immediate action. You can check the model number to confirm if your machine is affected, but no remedy is provided in this recall notice.
We’ve drafted a message you can send Siemens Medical Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-0730-2022 — Siemens Medical Solutions Siemens Medical Solutions Hello, I own a Siemens Medical Solutions that is covered by recall Z-0730-2022 from Siemens Medical Solutions. 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.