EOS Imaging: Medical Device Recall in 2018 - (Recall #: Z-3188-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

sterEOS workstation

Product Classification:

Class II

Date Initiated: August 1, 2018

Date Posted: September 26, 2018

Recall Number: Z-3188-2018

Event ID: 80938

Reason for Recall:

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.

Status: Terminated

Product Quantity: 17 units

Code Information:

All software versions are impacted

Distribution Pattern:

US nationwide

Voluntary or Mandated:

Voluntary: Firm initiated