BEUDAMED
    FDA Recall 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 · Initiated April 23, 2014

    Recall

    Recall Number
    Z-1576-2014
    Event Number
    68143
    Firm
    William C. Domb, D.M.D., A Professional Corporation
    FEI Number
    3009424396
    Product Code
    EIA
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    April 23, 2014
    Posted
    May 9, 2014
    Terminated
    January 8, 2015
    Address
    190 N. Mountain Ave., Upland, CA, 91786

    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.

    Action

    William Domb, DMD sent an Urgent Medical Device Recall letter on April 23, 2014, to all affected customers who purchased the Enaly 1000BT-12 Ozone Generator. The letter informed the customers of the problems identified, risk to health, and the actions to be taken. Customers were instructed to discontinue use of the Enaly 1000 BT-12 Ozone Generator and return their units to the following address: William Domb, DMD 190 N Mountain Avenue Upland, CA 91786 Customers were also instructed to complete the Medical Device Field Action Return Response form. For questions customers should contact William Domb at (909) 949-2968 or by email at [email protected] from Monday-Friday at 8am-5pm Pacific Time. For questions regarding this recall call (909) 949-2968.

    Distribution

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

    Quantity

    16 units