BEUDAMED
    FDA Recall Terminated

    Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.

    Recall: Z-1322-2010 · Initiated January 29, 2010

    Recall

    Recall Number
    Z-1322-2010
    Event Number
    54373
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    FKP
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    January 29, 2010
    Posted
    April 12, 2010
    Terminated
    February 3, 2011
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.

    Reason

    Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.

    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.

    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.

    Quantity

    443 boards