Class 2 Device Recall EOSedge imaging device

• Date Initiated by Firm: December 22, 2020
• Create Date: April 13, 2021
• Recall Status: Terminated on May 05, 2023
• Recall Number: Z-1415-2021
• Recall Event ID: 87505
• 510(K)Number: K202394
• Product Classification: System, x-ray, stationary - Product Code KPR
• 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.
• 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
• Recalling Firm/ Manufacturer: EOS Imaging; 4 Ieme Etage; 10 Rue Mercoeur; Paris France
• Manufacturer 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).
• FDA Determined 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 in Commerce: 11 devices
• Distribution: Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPR and Original Applicant = EOS imaging