Lower risk Medical device recall · FDA · Published March 10, 2021

Siemens Ysio X.pree Digital X-Ray System Recall: Risk of Wrong Patient Images

Siemens recalls Ysio X.pree digital X-ray systems (model 11107464) due to potential display of previous patient images during image recovery, risking misdiagnosis. Affected units have specific serial numbers.

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

🇺🇸 FDA recall #Z-1346-2021Medical device Siemens ›

Lower-risk recall

A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Siemens is recalling its Ysio X.pree digital X-ray systems (model 11107464) because a technical issue could show images from a previous patient instead of the current one during recovery. This might lead to incorrect diagnoses if the system disconnects during the process. Read more at govinfonow.com/recall/63108-siemens-ysio-x-pree-digital-x-ray-system-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63108-siemens-ysio-x-pree-digital-x-ray-system-recall-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1346-2021

Cite this page

“Siemens Ysio X.pree Digital X-Ray System Recall: Risk of Wrong Patient Images.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63108-siemens-ysio-x-pree-digital-x-ray-system-recall-risk. Based on FDA recall #Z-1346-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1346-2021%22&limit=1).

The FDA announced on March 10, 2021, that Siemens Medical Solutions USA, Inc. is recalling its Ysio X.pree digital X-ray system due to a hazard where patient images may be incorrectly assigned during recovery. This error could result in the display of a previous patient's image, potentially impacting diagnosis.

How to tell if you have it

Brand: Siemens
Product: Ysio X.pree
Model Number: 11107464
Serial Numbers: 10041, 10046, 10055, 10057, 10053, 10049, 10043, 10039, 10054, 10048, 10042, 10045
Units affected: 12

The hazard

According to the FDA, a patient image was assigned to a different patient during the image recovery process. If the connection to a MAX detector is interrupted, a previously acquired image may be displayed instead of the current one, potentially impacting the diagnosis of the patient examined.

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 Healthcare Centricity PACS Server V7 Recall (July 31, 2026), Philips Azurion X-Ray System Recall (June 17, 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 system. Affected units have specific serial numbers: 10041, 10046, 10055, 10057, 10053, 10049, 10043, 10039, 10054, 10048, 10042, 10045.

Brand
Siemens
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify if your system has any of the listed serial numbers: 10041, 10046, 10055, 10057, 10053, 10049, 10043, 10039, 10054, 10048, 10042, 10045.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

FDA distribution: “US Nationwide distribution in the states of FL, MN, OH, PA, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Minnesota, Ohio, Pennsylvania, Texas.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Mar 10, 2021Firm started the recall
Apr 2, 2021FDA classified it Class II
Apr 14, 2021Published in FDA’s Enforcement Report
Dec 11, 2023FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/63108-siemens-ysio-x-pree-digital-x-ray-system-recall-risk">Siemens Ysio X.pree Digital X-Ray System Recall: Risk of Wrong Patient Images (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-1346-2021 (March 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1346-2021 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.