BEUDAMED
    FDA Recall Terminated

    Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

    Recall: Z-0211-2015 · Initiated October 17, 2014

    Recall

    Recall Number
    Z-0211-2015
    Event Number
    69557
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    October 17, 2014
    Posted
    November 13, 2014
    Terminated
    April 6, 2016
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

    Reason

    Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power

    Action

    Maquet Inc. sent a Product Recall Urgent Medicall Device Field Correction letter to all of their customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter stated that a software upgrade will be performed by an authorized Maquet Service Technician. A Maquet representative will contact customer to schedule an on-site service of the device. Any questions can be directed to the local Maquet representative or Maquet Customer Service at 1-888-627-8383 (option 2, option 2) Monday through Friday, between the hours of 8:00 am and 6:00 pm (EST).

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    331 units