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Devices
Alsius CoolGard 3000 Temperature Regulation System
Model / Serial
All units manufactured before April 12, 2005.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas,
Product Description
Alsius CoolGard 3000 Temperature Regulation System
Manufacturer
Alsius Corporation
1 Event
Recall of Alsius CoolGard 3000 Temperature Regulation System
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Manufacturer
Alsius Corporation
Manufacturer Address
Alsius Corporation, 15770 Laguna Canyon Rd Ste 150, Irvine CA 92618-3111
Source
USFDA
Language
English
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