System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcar
FDA device recall Z-0179-2010 · posted 2009-11-12 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 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, Den
- Date initiated
- 2009-08-31
- Date posted
- 2009-11-12
- Date terminated
- 2010-11-15
- Location
- Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE (K013562) | Baxter Healthcare Corp | 2002-12-12 |
| ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM (K954987) | Althin Medical AB an Affiliate of Baxter Intl | 1996-08-08 |