Z-0179-2010

System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch...

Name: Z-0179-2010 System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch...
Creator: Baxter Healthcare Renal Div
Published: 2009-08-31
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2009-08-31 / Terminated / root cause: software

FDA source

Baxter Healthcare Renal Div began a recall of System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015... on 2009-08-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0179-2010
Status: Terminated
Initiated: 2009-08-31
Posted: 2009-11-12
Terminated: 2010-11-15
Recalling firm: Baxter Healthcare Renal Div
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 8,258 units
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 codes and lots: All systems with 4.B.09, 4.B.1.1 and 4.B.1.3 software.

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)