BEUDAMED
    FDA Enforcement Class II Terminated

    DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US

    Recall: Z-2747-2020 · Reported August 12, 2020

    Enforcement

    Recall Number
    Z-2747-2020
    Event ID
    85980
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2020
    Initiation Date
    June 30, 2020
    Classification Date
    July 31, 2020
    Termination Date
    November 17, 2020
    Address
    500 Gbc Dr, Newark, DE, 19702-2466, United States

    Description

    DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US

    Reason

    If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.

    Code Info

    DCA Vantage Handheld Barcode Scanner #11306432 Model: DS4308 - HC0015BZZWW

    Distribution

    Nationwide

    Quantity

    1800 units