Device recall

Z-1576-2014: Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone…

FDA device recall · Class II · William C. Domb, D.M.D., A Professional Corporation

Key facts

Recall number (Z-number) Z-1576-2014
Recall event 68143
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…
Product code EIA
Recalling firm William C. Domb, D.M.D., A Professional Corporation
Recall class Class II
Status Terminated
Termination date Jan 8, 2015
FEI number 3009424396

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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