Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Enaly 1000 BT12 Ozone Generator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Enaly 1000 BT12 Ozone Generator see related information
Date Initiated by Firm April 23, 2014
Date Posted May 09, 2014
Recall Status1 Terminated 3 on January 08, 2015
Recall Number Z-1576-2014
Recall Event ID 68143
Product Classification Unit, operative dental - Product Code EIA
Product 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.
Code Information Lot # 10BT-091237
Recalling Firm/
Manufacturer		 William C. Domb, D.M.D., A Professional Corporation
190 N. Mountain Ave.
Upland CA 91786
For Additional Information Contact
909-981-6400
Manufacturer 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.
FDA Determined
Cause 2		 No Marketing Application
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 bill@smilestudio.com from Monday-Friday at 8am-5pm Pacific Time. For questions regarding this recall call (909) 949-2968.
Quantity in Commerce 16 units
Distribution Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-