BEUDAMED
    FDA Recall Terminated

    SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.

    Recall: Z-1097-2017 · Initiated October 6, 2016

    Recall

    Recall Number
    Z-1097-2017
    Event Number
    76046
    Firm
    Soft Computer Consultants, Inc.
    FEI Number
    1000307651
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    October 6, 2016
    Terminated
    August 21, 2019
    Address
    5400 Tech Data Dr, Clearwater, FL, 33760-3116

    Description

    SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.

    Reason

    Software error. Potential for incorrect results

    Action

    Consignees were sent a recall notification, dated 10/06/2016, providing instructions for software correction. The firm indicates that the issue will be resolved with a mandatory hot fix. Hot fix will be released when its effectiveness is confirmed. Consignees are instructed to acknowledge receipt of the recall notification and grant permission for the recalling firm to load the hot fix when available. The firm can be contacted by calling Technical Support at 1-800-763-8522. Until the hot fix is available, consignees can still operate the software by exiting (Esc-Quit) the Test Verify option after each save changes (F12-Accept).

    Distribution

    Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica

    Quantity

    189 total