BEUDAMED
    FDA Enforcement Class II Terminated

    Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output.

    Recall: Z-1576-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1576-2014
    Event ID
    68143
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    William C. Domb, D.M.D., A Professional Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2014
    Initiation Date
    April 23, 2014
    Classification Date
    May 9, 2014
    Termination Date
    January 8, 2015
    Address
    190 N. Mountain Ave., Upland, CA, 91786, United States

    Description

    Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output.

    Reason

    William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.

    Code Info

    Lot # 10BT-091237

    Distribution

    Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.

    Quantity

    16 units