GE Healthcare, LLC: Medical Device Recall in 2013 - (Recall #: Z-0704-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

GE Healthcare Definium 5000/5220493-2 X-Ray System

Product Classification:

Class II

Date Initiated: September 26, 2012

Date Posted: March 6, 2013

Recall Number: Z-0704-2013

Event ID: 64134

Reason for Recall:

When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.

Status: Terminated

Product Quantity: 312 installed in US

Code Information:

Definium Model 5000/5220493-2

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated