Z-1415-2021Class II

The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at...

Name: Z-1415-2021 The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at...
Creator: EOS Imaging
Published: 2020-12-22
License: https://open.fda.gov/license/

EOS imaging / initiated 2020-12-22 / Terminated / root cause: software

FDA source

EOS Imaging began a recall of 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... on 2020-12-22. FDA classified it as Class II and gives the reason as "Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1415-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-22
Posted: 2021-04-13
Terminated: 2023-05-05
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.
Product code: KPR System, X-Ray, Stationary
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).
Root cause tag: software
FDA 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 in commerce: 11 devices
Distribution: Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1415-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1415-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-12

Product code KPR

K202394Class IIEOSedgeEos Imaging / cleared 2020-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)