FDAFDA · Food and drugs·Recall number Z-1877-2013
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Published August 21, 2013 · Recall initiated: June 3, 2013
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
Due to potential for an x-ray exposure technique change.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carestream Health Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
- Lot
- Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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