BEUDAMED
    FDA Enforcement Class II Ongoing

    Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

    Recall: Z-1376-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1376-2023
    Event ID
    91561
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Western/Scott Fetzer Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2023
    Initiation Date
    January 3, 2023
    Classification Date
    April 12, 2023
    Address
    875 Bassett Rd, N/A, Westlake, OH, 44145-1142, United States

    Description

    Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

    Reason

    Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxygen event and no flow.

    Code Info

    ROC-9839, Roberts Oxygen Ready to Use Digital VIPR (head only) o UDI-DI: B929ROC98390 ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) o UDI-DI: B929ROC98400 MNDR-600, Western Oxytote DTE Digital VIPR (head only) o UDI-DI: B929MNDR6000 MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) o UDI-DI: B929MNDS6020 MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder) o UDI-DI: B929MNDS6030 All units distributed from 05/29/2020 to 12/7/2022.

    Distribution

    US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.

    Quantity

    24,287 units