Siemens Medical Solutions USA, Inc System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in sitting, standing, or supine positions. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in sitting, standing, or supine positions.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
serail number 1192
Products Sold
serail number 1192
Siemens Medical Solutions USA, Inc is recalling System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which a due to It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.
Recommended Action
Per FDA guidance
Only one user in the United States is affected by this corrective action. The Customer Safety Advisory Notice was sent to the affected customer. Any additional communication regarding this corrective action will include the following statement: The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026