Lower risk Medical device recall · FDA · Published March 7, 2022

Siemens YSIO X.Pree X-ray Machine Recall: Collimation Display Error

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0730-2022Medical device Siemens Medical Solutions ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSiemens Medical Solutions USA, Inc40 Liberty Blvd · Malvern, PA 19355-1418

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/60983-siemens-ysio-x-pree-x-ray-machine-recall-collimation-display.

Source Summary by GovInfoNow · govinfonow.com/recall/60983-siemens-ysio-x-pree-x-ray-machine-recall-collimation-display · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0730-2022

Cite this page

“Siemens YSIO X.Pree X-ray Machine Recall: Collimation Display Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60983-siemens-ysio-x-pree-x-ray-machine-recall-collimation-display. Based on FDA recall #Z-0730-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0730-2022%22&limit=1).

The FDA announced on March 7, 2022, that Siemens Medical Solutions USA, Inc. is recalling YSIO X.Pree devices due to a user interface error showing incorrect collimation areas. The agency issued the recall under number Z-0730-2022 for Class II classification.

How to tell if you have it

Brand: Siemens Medical Solutions
Product: YSIO X.Pree
Model/Serial: 11107464

The hazard

The FDA said the User Interface displays a wider collimation area than preset, indicating an open collimator to the operator. The agency noted that the actual x-ray collimation performed correctly matches the predefined examination area.

Context

GovInfoNow's records show Siemens Medical Solutions USA, Inc. has 182 other recalls on record since June 6, 2017. Other recent recalls of similar products include GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026), GE Optima XR240amx Mobile X-Ray System Recall (June 5, 2026), and GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026).

How to tell if you have this one

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.

Brand
Siemens Medical Solutions
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Verify the model number on your YSIO X.Pree x-ray machine to confirm it is 11107464.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US Nationwide, Worldwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

Mar 7, 2022Firm started the recall
Apr 5, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Siemens Medical Solutions recalls

Link to this recall

<a href="https://govinfonow.com/recall/60983-siemens-ysio-x-pree-x-ray-machine-recall-collimation-display">Siemens YSIO X.Pree X-ray Machine Recall: Collimation Display Error (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0730-2022 (March 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0730-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.