EOS Imaging: Medical Device Recall in 2021 - (Recall #: Z-1415-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 22, 2020

Date Posted: April 21, 2021

Recall Number: Z-1415-2021

Event ID: 87505

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).

Status: Terminated

Product Quantity: 11 devices

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated