BEUDAMED
    FDA Recall Terminated

    RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778

    Recall: Z-2432-2020 · Initiated May 27, 2020

    Recall

    Recall Number
    Z-2432-2020
    Event Number
    85750
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 27, 2020
    Terminated
    January 12, 2021
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778

    Reason

    The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.

    Action

    On May 27, 2020, the firm notified customers via Urgent Field Safety Notice letters. Product was distributed to foreign customers only. Customers were instructed to complete and return the included customer response form. Customers whose systems are not configured to use code 39 with check-digit need take no further action. However, for customers whose systems are configured to use code 39 with check-digit, the customer notice provided two workaround options: 1) Use the integrated on-board barcode scanner, or 2) Re-configure the handheld barcode scanner following the instructions in the letter. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative

    Distribution

    Foreign distribution only.

    Quantity

    436