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FDADecember 22, 2020device

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. ¿ ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

eos imagingeos

UPCs

03663999000108

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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