Baxter Healthcare Renal Div 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
All systems with 4.B.09, 4.B.1.1 and 4.B.1.3 software.
Products Sold
All systems with 4.B.09, 4.B.1.1 and 4.B.1.3 software.
Baxter Healthcare Renal Div is recalling System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTou due to When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's manual.
Recommended Action
Per FDA guidance
Baxter sent an Urgent Device Correction letter dated August 31, 2009 to all System 1000 Series of Hemodialysis Instruments customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that a software anomaly in software versions 4.B.0.9, 4.B.1.1 and 4.B.1.3 was discovered when the main power was lost temporarily during a simulated treatment. The anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's Manual. The accounts were informed that instruments with software versions 4.B.0.9, 4.B.1.1 and 4.B.1.3 will be upgraded to version 4.B.1.4 software, provided the instruments have a 486 Motherboard or Single Board Computer, and that instruments containing versions of 4.A software are not affected. The accounts were requested to complete the enclosed Customer Reply form, indicating the instrument serial number and software version for each machine at the site, and if they would be requesting Baxter Technical Services to upgrade their instruments or have the software sent to them to make the upgrades, and fax the sheet to 1-847-270-5457. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 4, option 1.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026