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 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.

Recall number

Z-1415-2021

Recalling firm

EOS Imaging

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.

Status

Terminated

Initiated

2020-12-22

Posted

not on file

Terminated

2023-05-05

Reason

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

Root cause

Software design

Action

A recall notification letter titled, "Field Safety Notice (FSN1 REG-2020-0001-A) Safety information concerning the EOSedge imaging device, was sent to the US consignees on 12/22/2020 via certified mail, followed by a phone call to one of the consignees and hand delivery to the other U.S. consignee. The OUS consignees were provided notification beginning on 12/30/2020 either by sending of a certified mail plus an email to direct customer consignees or by sending of an email to distributors for countries where the EOSedge distribution is not made directly by EOS imaging, i.e. Australia and Spain. The consignee is requested to: 1) Please read the field safety notice. 2) Follow the instructions provided in this field safety notice. 3) Please transfer this notice to whomever needs to be informed within the consignee's organization or in any organization to which the device may have been transferred. The instructions provided in the notice goes as follows: "EOSedge users are requested not to combine acquisition of patients in orientation different than AP with reference plane modification at REVIEW step. Users of the sterEOS workstation are requested to systematically display reference planes and check they are properly positioned before performing modeling or measurement, sending to PACS and carrying out a diagnosis. Same verification can be performed on sterEOS with images previously acquired, and correction can be applied for retrospective measurements if necessary."

Quantity

11 devices

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K202394"]

PMA numbers

not on file

Product code

KPR

Firm FEI

3006165260

Firm city

Paris

Firm state

not on file

Firm country

France

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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