BEUDAMED
    FDA Enforcement Class II Terminated

    Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.

    Recall: Z-1692-2015 · Reported June 10, 2015

    Enforcement

    Recall Number
    Z-1692-2015
    Event ID
    70793
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2015
    Initiation Date
    March 21, 2015
    Classification Date
    May 29, 2015
    Termination Date
    November 20, 2015
    Address
    1265 Grey Fox Rd, N/A, Saint Paul, MN, 55112-6929, United States

    Description

    Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.

    Reason

    The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.

    Code Info

    Serial Numbers: 4059587 through 4059591 UPDATED 4-20-2015: additional devices affected have serial numbers: 4059949, 4059950, 4059951, 4059952, 4059953, 4059954, 4059955, 4059957, 4059958 and 4059960

    Distribution

    MN

    Quantity

    5 UPDATE 4-20-2015 to include 10 additional devices