BEUDAMED
    FDA Enforcement Class II Ongoing

    CLEO Patient Monitor /Tranquility VS Patient Monitor

    Recall: Z-1926-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1926-2019
    Event ID
    82999
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Infinium Medical, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 10, 2019
    Initiation Date
    May 31, 2019
    Classification Date
    July 2, 2019
    Address
    12151 62nd St Ste 5, N/A, Largo, FL, 33773-3702, United States

    Description

    CLEO Patient Monitor /Tranquility VS Patient Monitor

    Reason

    The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.

    Code Info

    Serial Numbers - A18094501812, A18014501391, A18014600053, A18014600070, A18014600080, A18014501432, A18014501438, A17074501202, A17084501263, A17024500996, A16054500521, 45000082, 45000084, 45000085, 45000057,45000058, A1 8094501659, A17044501052, A17024500972, A160104500653, A160104500674, A160104500685, A160104500701, A16084500604, A16084500605, A15104500320, A15 104500407, A15104500257, 45000083, 45000043, 45000044, 45000045, A17024500996, A18094501642, A18094501674, A18094501696, A17074501227, 45000072, 48000001, 48000002, 48000003, A1 8094501639, A18094501652, A18094501657, A18094501702, A18094501719, A18044600082, A18044600083, A18044600087, A18044600089, A18044600092, A17124501378, A17124501384, A17124501385, A17124501386, A17124501387, A17024800002, A17024800004, A17024800006, A17024800007, A17024800008, A17024800012, A17024800013, A17024800018, A17024800021, A17024800022, A17024800024, A17024800028, A17024800030, A1702480003 1, A17024800032, A17024800039, A17024800043, A17024800046, A17024800048, A17024800050, A17024800009, A17024800014, A17024800015, A17024800016, A17024800017, A17024800019, A17024800020, A17024800025, A17024800026, A17024800027, A17024800029, A17024800033, A17024800034, A17024800037, A17024800038, A17024800040, A17024800042, A17024800044, A17024800047, A17024800049.

    Distribution

    Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.

    Quantity

    95 devices