Devices

Kodak DirectView DR 71 System

Model / Serial
s/n DR71000121 and DR71000123.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7 hospitals in China, 1 warehouse in China; 1in the possession of Chinese Customs (government); and 1 is in a warehouse in Russia.
Product Description
KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
Manufacturer
Eastman Kodak Co
1 Event
- Recall of Kodak DirectView DR 71 System

Manufacturer

Eastman Kodak Co

Manufacturer Address
Eastman Kodak Co, 343 State St, Rochester NY 14650
Source
USFDA

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