The Recall Desk
ModerateFDA (Devices)·Z-1415-2021·Announced 2021-04-21

EOS Imaging Recalls EOSedge Systems Due to Measurement Errors

EOS Imaging is recalling 11 EOSedge systems because they may produce inaccurate 2D measurements and image resizing errors when patients are not positioned antero-posteriorly.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard involves software measurement errors rather than direct physical injury or contamination, fitting the criteria for a moderate severity issue where the risk is primarily diagnostic inaccuracy.

Plain-English summary

EOS Imaging is recalling 11 EOSedge systems, which are medical devices used to acquire low-dose, two-dimensional images of standing or seated patients. The recall is due to a software issue where inadequate image resizing and 2D measurement errors may occur if a biplanar acquisition is performed with a patient orientation different from antero-posterior (AP).

The affected devices were distributed nationwide to Minnesota and Ohio, as well as internationally to Australia, Canada, Germany, Spain, and France. The specific serial numbers for the 11 units involved in this recall are 8.1912.1008, 8.2001.1010, 8.2001.1011, 8.2002.1012, 8.1907.1005, 8.1909.1006, 8.2005.1014, 8.1905.1004, 8.1911.1007, 8.1912.1009, and 8.2006.1016.

Healthcare facilities and users should check their device serial numbers against the list provided by EOS Imaging. If a device is affected, users should contact the manufacturer for instructions on how to resolve the issue, which may involve software updates or other corrective actions to ensure accurate image processing and measurements.

The recalled product

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 acquisitio
Manufacturer
EOS Imaging
Category
Medical Device — Imaging Equipment
Hazard
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Product Reference:03663999000108
  • Serial Numbers: 8.1912.1008
  • 8.2001.1010
  • 8.2001.1011
  • 8.2002.1012
  • 8.1907.1005
  • 8.1909.1006
  • 8.2005.1014
  • 8.1905.1004
  • 8.1911.1007
  • 8.1912.1009
  • and 8.2006.1016

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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