# FDA recall Z-1415-2021

> **EOS Imaging** · Class II · device recall initiated 2020-12-22.

## 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).

## Distribution

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

## Key facts

- **Recall number:** Z-1415-2021
- **Recalling firm:** EOS Imaging
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-22
- **Report date:** 2021-04-21
- **Termination date:** 2023-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Paris, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1415-2021

## Citation

> AI Analytics. FDA recall Z-1415-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1415-2021. Source: US FDA. Licensed CC0.

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