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Terminated

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

FDA Recall Z-0704-2013 · Posted 2013-02-27

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAC
Date Initiated2012-09-26
Date Terminated2013-12-05
Product Quantity312 installed in US

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.

Firm Action

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

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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