EOS Imaging: Medical Device Recall in 2014 - (Recall #: Z-0529-2014)

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:

EOS System X- ray beam Digital radiography system used in general radiographic examinations.

Product Classification:

Class II

Date Initiated: November 7, 2013
Date Posted: January 15, 2014
Recall Number: Z-0529-2014
Event ID: 66833
Reason for Recall:

EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.

Status: Terminated
Product Quantity: 22 EOS systems are installed in US
Code Information:

EOS System

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated