Z-1322-2010

Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015...

Name: Z-1322-2010 Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015...
Creator: Baxter Healthcare Renal Div
Published: 2010-01-29
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2010-01-29 / Terminated / root cause: software

FDA source

Baxter Healthcare Renal Div began a recall of Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and... on 2010-01-29. The reason FDA records is "Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software". 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-1322-2010
Status: Terminated
Initiated: 2010-01-29
Posted: 2010-04-12
Terminated: 2011-02-03
Recalling firm: Baxter Healthcare Renal Div
Product: Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
Product code: FKP System, Dialysate Delivery, Single Patient
Reason for recall: Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.
Root cause tag: software
FDA root cause: Software change control
Action: An "Urgent Device Correction" letter dated January 29, 2010 was sent to the direct accounts via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letter informed the accounts that subsequent to a prior device field correction in 2003-2004, some 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software. The accounts were instructed to confirm the software version in their systems and replacement boards. Instructions for checking the software version were attached to the letter. A complementary software upgrade will be made available to the account if their 1550 instrument and/or spare circuit board inventory has a software version other than 3.0A or 4.1B. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and listing the serial numbers and software versions of those instruments that do nit have software 3.0A or 4.1B. Home patients were not notified directly, the information was sent to their Dialysis Center. The 1550 operator's manual was revised during the 2003 device field correction. The manual correctly warns the operator to discontinue treatment if the 1550 experiences a FL04, FL07, or FLOg fault code. To make arrangements for the software upgrade or questions regarding the communication were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3. For additional questions, contact the company Monday through Friday from 8:00 AM to 5:00 PM CST at (Toll Free): 800-422-9837.
Quantity in commerce: 443 boards
Distribution: Worldwide Distribution -- United States - nationwide and Puerto Rico, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela.
Product codes and lots: All Baxter 1550 instruments and/or spare circuit boards that do not have software versions 3.0A or 4.1B

Product code FKP

K883111Class IIHeomdialysis Single Patient System (Sps) Model 650Baxter Healthcare Corp / cleared 1989-02-08

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)