FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
- Recall number
- Z-0831-06
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
- Status
- Terminated
- Initiated
- 2006-03-29
- Posted
- 2006-05-03
- Terminated
- 2008-02-26
- Reason
- Software Error: There are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
- Root cause
- Other
- Action
- Baxter sent Urgent Device Correction letters dated 3/29/06 to those customers who had their RenalSoft and Renal Software Suite software configured with the affected modules. The letters indicated in a table which software anomalies were associated with the affected software modules in each software version. A description of each anomaly was provided, along with interim actions to take to mitigate the anomaly until the new software version RenalSoft V.2.0.x can be issued. Individual customer training will be performed at each facility for those issues identified in the letter specific to their software version. At that time the mitigation provided in the letter will be reviewed with the customer.
- Quantity
- 12 - U.S, 104 - International
- Distribution
- Nationwide (Alabama, Arizona, California, Colorado, Connecticut, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, Pennsylvania, South Dakota,Texas and Wisconsin); and internationally to Australia, Austria, Canada, Denmark, Finland, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.
- Lot, serial or model codes
- version 2.0 - HD Modules, PD Modules and Medical Record Modules only
- 510(k) numbers
- ["K990953"]
- PMA numbers
- not on file
- Product code
- KPF
- Firm FEI
- 3000210122
- Firm city
- Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28