The EOSedge system may acquire two simultaneous orthogonal planar… — Class II medical device recall Z-1415-2021
Terminated recall by EOS Imaging, reported 2021-04-21, distributed nationwide. Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed wi
| Recall number | Z-1415-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EOS Imaging, Paris, N/A, France |
| Recall initiated | 2020-12-22 |
| Classified | 2021-04-12 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2023-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, ES, FR |
| Quantity | 11 devices |
| UPC / GTIN / UDI-DI | 03663999000108 |
| Serial numbers | 1010, 1011, 1012, 1014, 1016, 8.1905.1004, 8.1907.1005, 8.1909.1006, 8.1911.1007, 8.1912.1008, 8.1912.1009 |
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1415-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.