BEUDAMED
    FDA Recall Terminated

    Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)

    Recall: Z-1208-03 · Initiated August 11, 2003

    Recall

    Recall Number
    Z-1208-03
    Event Number
    26903
    Firm
    Harvard Clinical Technology
    FEI Number
    1218257
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2003
    Posted
    September 11, 2003
    Terminated
    May 7, 2012
    Address
    22 Pleasant Street, South Natick, MA, 01760

    Description

    Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)

    Reason

    Under specific sequence conditions, the unit may apper to be infusing, but is not

    Action

    Harvard Medical Technology inc. notified customers by letter on 8/11/03, advising users of the software upgrade to version V1.3T. Facilities will be visited by technicians who will upgrade the software.

    Distribution

    Nationwide

    Quantity

    384 units