BEUDAMED
    FDA Recall Terminated

    Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

    Recall: Z-1050-04 · Initiated April 5, 2004

    Recall

    Recall Number
    Z-1050-04
    Event Number
    29424
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 5, 2004
    Posted
    July 20, 2004
    Terminated
    January 19, 2005
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-0619

    Description

    Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.

    Reason

    Potential inaccurate printed information in the upper and lower margins of a print strip.

    Action

    Datascope initiated this field action in February, 2004. Datascope Service Representatives are visiting the customers and doing the retrofit.

    Distribution

    The units were shipped to hospitals and clinics nationwide. Also to Australia, Brazil, Belgium, France, Germany,Turkey, United Kingdom, United Arab Emirates. One unit was shipped to the VA Medical Center, Augusta, GA.

    Quantity

    202