BEUDAMED
    FDA Recall Terminated

    System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China.

    Recall: Z-1813-2010 · Initiated May 10, 2010

    Recall

    Recall Number
    Z-1813-2010
    Event Number
    55649
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 10, 2010
    Posted
    June 21, 2010
    Terminated
    October 27, 2010
    Address
    15 Law Dr, Fairfield, NJ, 07004-0011

    Description

    System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and Hong Kong/China.

    Reason

    Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen.

    Action

    Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.

    Distribution

    Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.

    Quantity

    161 units total