FDAFDA · Food and drugs·Recall number Z-1576-2014
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.
Published May 21, 2014 · Recall initiated: April 23, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- William C. Domb, D.M.D., A Professional Corporation
- Distributor
- Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.
- Lot
- Lot # 10BT-091237
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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