Devices

Device Recall Kodak DirectView DR 7500 Diagnostic XRay System

Model / Serial
The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.
Product Description
Kodak DirectView DR 7500 Diagnostic X-Ray System || Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system 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 DR 7500 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 Diagnostic XRay System

Manufacturer

Carestream Health, Inc.

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

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