Devices

Device Recall Kodak DirectView DR 7500 System with motorized Wall Stand (WS)

Model / Serial
Catalog Numbers: 8551046, 8791345, 1333483, 8649253, 8864605, 1155118, 1295088, 1666700, 1845122, 1671841, 8245607, 8531675, 8966780; Service Code: 8087
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
DR 7500 with FF 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 Kodak DirectView DR 7500 System with motorized 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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