BEUDAMED
    FDA Recall Terminated

    Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

    Recall: Z-1567-05 · Initiated August 19, 2005

    Recall

    Recall Number
    Z-1567-05
    Event Number
    33230
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    DRT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 19, 2005
    Posted
    September 21, 2005
    Terminated
    June 21, 2006
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-2001

    Description

    Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.

    Reason

    The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.

    Action

    A recall letter was sent to the consignees on 8/19/2005.

    Distribution

    The affected software was distributed to 108 domestic sites and seven international sites. There are no sale of affected Panorama software to the US Govt.

    Quantity

    115 units