Devices

Device Recall Carestream DRXEvolution with Carestream Health (CSH) Wall Stand (WS)

Model / Serial
Catalog Numbers: 1731678, 1731660, 1010990, 1030451, 1016138, 1030477, 1010982, 1030485; Service Code: 7171
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Product Description
DRX-Evolution with CSH WS || 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 wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Manufacturer
Carestream Health, Inc.
1 Event
- Recall of Device Recall Carestream DRXEvolution with Carestream Health (CSH) Wall Stand (WS)

Manufacturer

Carestream Health, Inc.

Manufacturer Address
Carestream Health, Inc., 1049 Ridge Rd W, Rochester NY 14615-2731
Manufacturer Parent Company (2017)
ONEX Corp
Source
USFDA

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