BEUDAMED
    FDA Enforcement Class II Terminated

    SAROS Oxygen System Model 3000

    Recall: Z-0248-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0248-2020
    Event ID
    83850
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Caire, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 6, 2019
    Initiation Date
    September 16, 2019
    Classification Date
    October 30, 2019
    Termination Date
    December 16, 2020
    Address
    2200 Airport Industrial Dr Ste 500, Ball Ground, GA, 30107-4686, United States

    Description

    SAROS Oxygen System Model 3000

    Reason

    There is an electronics control issue that causes the unit to not power on with battery power only.

    Code Info

    Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, CBB0818281052

    Distribution

    US and Chile

    Quantity

    10 units