EOS Imaging: 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

Is my product affected?

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

• UPC 03663999000108

Check against the official notice below — it lists the full affected range.

What happened

The EOSedge imaging system, which captures low-dose X-ray images of standing or seated patients, has been recalled because it may produce inadequate image resizing and inaccurate 2D measurements when biplanar images are acquired with patient orientations other than AP (Antero-Posterior). Eleven devices with specific serial numbers were distributed nationwide in Minnesota and Ohio, as well as internationally in Australia, Canada, Germany, Spain, and France.

The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior). Distribution: Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France Quantity: 11 devices Lot/code info: Product Reference:03663999000108; Serial Numbers: 8.1912.1008, 8.2001.1010, 8.2001.1011, 8.2002.1012, 8.1907.1005, 8.1909.1006, 8.2005.1014, 8.1905.1004, 8.1911.1007, 8.1912.1009, and 8.2006.1016

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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