EOS Imaging: Medical Device Recall in 2014 - (Recall #: Z-0580-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

Product Classification:

Class II

Date Initiated: November 29, 2013
Date Posted: January 1, 2014
Recall Number: Z-0580-2014
Event ID: 66980
Reason for Recall:

Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation

Status: Terminated
Product Quantity: 36 units
Code Information:

Software versions: 1.3, 1.4 and 1.5

Distribution Pattern:

USA Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated