Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

sterEOS workstation Recalled by EOS Imaging Due to 3D projections may be incorrect when the pair...

Date: August 1, 2018
Company: EOS Imaging
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact EOS Imaging directly.

Affected Products

sterEOS workstation

Quantity: 17 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About EOS Imaging

EOS Imaging has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report