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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:124636

Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.

Official recall number

Z-0774-2014

Evidence summary

Product code
KPR
Recall status
Terminated
Event initiated
August 20, 2013
Root cause
Radiation Control for Health and Safety Act
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0774-2014