The EOSedge system may acquire two simultaneous orthogonal… recallZ-1415-2021 · EOS Imaging · initiated Dec 22, 2020

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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."

Recall details

Recall number

Z-1415-2021

Status

Terminated

Initiated by the company

Dec 22, 2020

Recalling firm

EOS Imaging

Quantity

11 devices

Product code

KPR

FDA submissions

K202394

Distribution

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

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• EOSedge™ 2.1

  Eos Imaging · System, X-Ray, Stationary
  1 recall0 reports