Device Recall System 1000, TINA, AURORA and Altratouch
Modèle / numéro de série
product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2; all serial numbers within the range of 1001 through 22000
Nationwide including Puerto Rico, and internationally to Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Lebanon, Morocco, the Netherlands, Nigeria, Oman, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, UAE, UK, Turkey, Colombia, Dominican Republic, Trinidad, Jamaica, St. Croix, Brazil, Peru, Ecuador, Australia, Argentina, Paraguay, Uruguay, China, Korea, Taiwan, Philippines, India, Singapore, Malaysia, Thailand, Indonesia and Canada.
Description du dispositif
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Worldwide Distribution -- United States (including Puerto Rico and the Virgin Islands), Algeria, Argentina, Austria, Bahrain, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, India, Indonesia, Ireland, Italy, Jordan, Korea, Latvia, Lebanon, Lithuania, Malaysia, Mauritania, Mexico, Morocco, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, Saipan, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay and Venezuela.
Description du dispositif
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. || The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers.