Class II — EOS Imaging
| Recalling firm | EOS imaging |
|---|---|
| Registered facility | EOS imaging (the firm's only registered facility) |
| Classification | Class II |
| 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). |
| 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 u… |
| Quantity | 11 devices |
| Distribution | Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France |
| Initiated | 2020-12-22 |
| Classified | 2021-04-12 |
| Terminated | 2023-05-05 |
| Recall number | Z-1415-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — EOS Imaging (Z-1415-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87505/
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