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Devices
Device Recall Innova 2000 and Innova 2000 S; and Innova 2000 and Innova 2000S mobile version
Model / Serial
all serial numbers
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela
Product Description
GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.
Manufacturer
GE Healthcare
1 Event
Recall of Device Recall Innova 2000 and Innova 2000 S; and Innova 2000 and Innova 2000S mobile version
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Manufacturer
GE Healthcare
Manufacturer Address
GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Manufacturer Parent Company (2017)
General Electric Company
Source
USFDA
Language
English
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