FDA recall Z-1764-2020

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.

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

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2020-04-06

Report date

2020-05-13

Termination date

2020-10-27

Voluntary/Mandated

FDA Mandated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1764-2020