Paris, N/A, France
EOS Imaging recalls
2 recalls recorded since 2018, most recently on 22 December 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 December 2020
- Terminated
- 5 May 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1415-2021
- 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
Terminated Class II Medical devices
- Recall started
- 1 August 2018
- Terminated
- 15 August 2022
- Reason
- 3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.
- Distribution
- US nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3188-2018
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.