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EOS Imaging recalls The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. T
Recalled April 21, 2021 · FDA recall Z-1415-2021 · EOS Imaging
Hazard
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior). · FDA Class II
Units
11 devices
Sold at
Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France
Description
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
Product
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.
Manufacturer(s)
EOS Imaging
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →