FDAFDA · Food and drugs·Recall number Z-0704-2013
GE Healthcare Definium 5000/5220493-2 X-Ray System
Published March 6, 2013 · Recall initiated: September 26, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Nationwide Distribution
- Lot
- Definium Model 5000/5220493-2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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