BEUDAMED
    FDA Recall Terminated

    Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

    Recall: Z-1279-2022 · Initiated May 2, 2022

    Recall

    Recall Number
    Z-1279-2022
    Event Number
    90250
    Firm
    Getinge Usa Sales Inc
    FEI Number
    3013876692
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 2, 2022
    Posted
    June 23, 2022
    Terminated
    August 6, 2024
    Address
    1 Geoffrey Way, Wayne, NJ, 07470-2035

    Description

    Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

    Reason

    Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.

    Action

    Maquet Critical Care AB/Getinge initiated a voluntary Medical Device Correction Letter on 5/2/22. . Examine your inventory immediately to determine if you have any of the Flow-c and/or Flow-e anesthesia system(s) with the serial numbers as listed in this notice. . You may continue use of the affected device ensuring that the recommended daily system check out (SCO) and pre-anesthesia checkout procedures are followed as listed in the Operators Manual. . Check for functionality of the suction unit. If you detect a cracked or broken on/off switch before starting a new case, the anesthesia machine should be replaced with a fully functioning anesthesia machine or you should ensure that a temporary alternative suction substitution is available. . Customers with affected system(s) will be contacted by a Getinge Service Representative to schedule on-site correction of your device. You can arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between 8 am and 6 pm (Eastern Time Zone). Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Correction - RESPONSE FORM to acknowledge receipt of this notification. Return the completed form to Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to (877) 548-4901. Action by the Getinge: Maquet Critical Care AB/Getinge has identified the cause of the issue. A solution that will correct this issue has been developed and your unit will be corrected at no cost to you by replacing the on/off switch with a new, more durable one.

    Distribution

    US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia

    Quantity

    47 units US