Z-1765-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- April 6, 2020
- Termination Date
- October 27, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 399 (wordwide)
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution
Code Information
serail number 1192