Home / Recalls / William C. Domb, D.M.D., A Professional Corporation / Z-1576-2014

Z-1576-2014 Class II Terminated

Recalled by William C. Domb, D.M.D., A Professional Corporation — Upland, CA

Recall Details

Product Type
Devices
Report Date
May 21, 2014
Initiation Date
April 23, 2014
Termination Date
January 8, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 units

Product 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 for Recall

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

Distribution Pattern

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

Code Information

Lot # 10BT-091237