Recall Z-1764-2020 ยท KPR System, X-Ray, Stationary
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 sitti
| Date | Apr 6, 2020 |
| Status | Terminated |
| Reason | 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 | 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 | 314 (wordwide) |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013826 | AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) Siemens Medical Systems, Inc., Feb 1, 2002 |