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

FDA device recall Z-0704-2013 · posted 2013-02-27 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. A GE Healthcare Service Representative will update the software on the system to address the issue. Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.

Root cause

Software design

Status

Terminated

Product code

JAC

Quantity affected

312 installed in US

Distribution

Nationwide Distribution

Date initiated

2012-09-26

Date posted

2013-02-27

Date terminated

2013-12-05

Location

Waukesha, WI