Class 2 Device Recall Siemens AXIOM Aristos FX

• Date Initiated by Firm: April 06, 2020
• Create Date: May 05, 2020
• Recall Status: Terminated on October 27, 2020
• Recall Number: Z-1764-2020
• Recall Event ID: 85448
• 510(K)Number: K013826
• Product Classification: System, x-ray, stationary - Product Code KPR
• 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.
• Code Information: serail number 1192
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355
• For Additional Information Contact: 610-219-4834
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: 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
• Quantity in Commerce: 314 (wordwide)
• Distribution: Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPR and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.