Recall Z-1415-2021 ยท KPR System, X-Ray, Stationary
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 freq
| Date | Dec 22, 2020 |
| Status | Terminated |
| 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 |
| Quantity | 11 devices |
| Distribution | Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202394 | EOSedge Eos Imaging, Sep 16, 2020 |