Reported Apr 21, 2021 · Terminated
The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose.…
EOS Imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: EOS Imaging · 4 Ieme Etage · Paris, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Product Reference03663999000108
- Serial Numbers
8.1912.10088.2001.10108.2001.10118.2002.10128.1907.10058.1909.10068.2005.10148.1905.10048.1911.10078.1912.1009and 8.2006.1016
- Amount recalled
- 11 devices
Where it was sold
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).
This product could cause temporary or reversible health problems — stop using it.
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