Devices

Device Recall System 1000, TINA, AURORA and Altratouch

Model / Serial
product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2; all serial numbers within the range of 1001 through 22000
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Manufacturer
Baxter Healthcare Renal Div
1 Event
- Recall of Device Recall System 1000, TINA, AURORA and Altratouch

Manufacturer

Baxter Healthcare Renal Div

Manufacturer Address
Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
Source
USFDA

One device with a similar name

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Device Recall System 1000, TINA, AURORA and AltraTouch

Model / Serial
All systems with 4.B.09, 4.B.1.1 and 4.B.1.3 software.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
Baxter Healthcare Renal Div

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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