BEUDAMED
    FDA Enforcement Class II Terminated

    A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.

    Recall: Z-0846-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0846-2018
    Event ID
    79133
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. dba Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 14, 2018
    Initiation Date
    July 14, 2017
    Classification Date
    March 2, 2018
    Termination Date
    April 17, 2019
    Address
    800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States

    Description

    A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.

    Reason

    A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.

    Code Info

    Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    2875 in total