BEUDAMED
    FDA Recall Terminated

    TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

    Recall: Z-1493-2019 · Initiated April 5, 2019

    Recall

    Recall Number
    Z-1493-2019
    Event Number
    82727
    Firm
    Abbott Laboratories Inc. (St Jude Medical) One
    FEI Number
    1000139754
    Product Code
    OAE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 5, 2019
    Terminated
    April 27, 2021
    Address
    St. Jude Medical Drive, Saint Paul, MN, 55117

    Description

    TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

    Reason

    In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.

    Action

    The recall notice, and clinician acknowledgment form were hand delivered by Abbott Sales Representatives to all impacted accounts starting April 5, 2019. Completed Clinician Acknowledgement Forms, signify they received the correction notification for the impacted TactiSys Quartz Equipment with software version 1.7.

    Distribution

    US, UNITED KINGDOM, UAE, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDIA ARABIA, RUSSIA, ROMANIA, PORTUGAL, POLAND, PALESTINE, OMAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAN, GREECE, GERMANY, FRANCE, EL SALVADOR, EGYPT, DENMARK, Czech Republic, CHINA, CANADA, BULGARIA, BELGIUM, AUSTRIA, AUSTRALIA

    Quantity

    317 units