BEUDAMED
    FDA Recall Open, Classified

    Puritan Bennett 560 Ventilator, PB560, CFN 4096600

    Recall: Z-1775-2022 · Initiated August 19, 2022

    Recall

    Recall Number
    Z-1775-2022
    Event Number
    90766
    Firm
    Covidien Llc
    FEI Number
    3002807850
    Product Code
    QOS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 19, 2022
    Posted
    September 22, 2022
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    Puritan Bennett 560 Ventilator, PB560, CFN 4096600

    Reason

    Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.

    Action

    Consignees were notified by letter delivered beginning August 19, 2022. Medtronic is advising that continued use of PB560 ventilators is appropriate when the actions listed in the recall letter are taken into consideration, unless this continued use is inconsistent with facility internal policies and procedures. All affected units require turbine replacement. Customers should contact Medtronic Service at 1-800-255-6774 to arrange for required service to replace the affected ventilator turbine component. If you have any questions regarding this communication, please contact your Medtronic representative or Technical Service at 1-800-255-6774.

    Distribution

    Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.

    Quantity

    5 US