BEUDAMED
    FDA Recall Open, Classified

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

    Recall: Z-1907-2023 · Initiated May 4, 2023

    Recall

    Recall Number
    Z-1907-2023
    Event Number
    92214
    Firm
    Datascope Corp.
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 4, 2023
    Posted
    June 14, 2023
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

    Reason

    The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

    Action

    An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION notification letter was sent to customer on 5/4/23. Actions to be taken by the customer: " Please locate the CARDIOSAVE Hybrid IABPs with the serial numbers listed in this notice. " Please ensure that all Cardiosave Hybrid Intra-Aortic Balloon Pump users at your facility are aware of this notice. " Please forward this information to all current and potential Cardiosave Hybrid IABPs users within your hospital / facility. " Please contact your local Getinge Service Representative to arrange to have the affected IFU USB drives replaced. " Please complete and sign the attached URGENT FIELD SAFETY NOTICE RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Datascope Corp./Getinge by e-mailing a scanned copy to [email protected] Actions to be taken by Getinge: Getinge will provide your facility with an updated IFU USB drive that contains reference to the vibration testing standard, 60601-1-12:2014. The original USB drive that was provided during the D.00 software update can be destroyed locally. This voluntary correction notification only affects the products listed on page 1; no other products are affected by this voluntary correction. We apologize for any inconvenience this Medical Device Correction may cause. If you have any questions, please contact your Datascope Corp./Getinge representative.

    Distribution

    International distribution in the country of Germany.

    Quantity

    4 units