EOS Imaging recalls The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose.…

Recall date

December 22, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1415-2021

FDA classification

Class II

Brand / firm

EOS Imaging

Sold / distributed

Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France

Why it was recalled

Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.