Device product
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.
Z-1877-2013
Product summary
- Event
- Event 65369
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 49 units; Foreign: 183 units (revised)
- Official record key
device-enforcement:Z-1877-2013
Official wording
Reason: Due to potential for an x-ray exposure technique change.
Code information: Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software
Distribution pattern: 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.
Derived failure modes
-
Unknown
Due to potential for an x-ray exposure technique change.