BEUDAMED
    FDA Recall Terminated

    Servo-I ventilator system CO2 analyzer. Part number 65 23 588.

    Recall: Z-1224-2015 · Initiated January 12, 2015

    Recall

    Recall Number
    Z-1224-2015
    Event Number
    70224
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    CBN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 12, 2015
    Posted
    February 27, 2015
    Terminated
    May 15, 2017
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Servo-I ventilator system CO2 analyzer. Part number 65 23 588.

    Reason

    A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.

    Action

    Maquet sent an Urgent Product Recall Medical Device Action Field Removal Letter dated 1/12/2015 via FedEx.

    Distribution

    Worldwide distribution - USA nationwide, Austria, Australia, Belgium, Chile, Canada, Colombia, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Italy, Japan, Libya, Netherlands, Norway, Panama, Peru, Portugal, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.

    Quantity

    486 units