—#180901

Product

System AXIOM Aristos FX Plus - 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; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. It is not designed for mammography use. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K061054
Affected lot / code info: serail number 1192

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2020-04-06
Terminated: 2020-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.