Device recall
Z-1308-2009: Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South…
FDA device recall · Class II · Sybaritic, Inc
Key facts
| Recall number (Z-number) | Z-1308-2009 |
|---|---|
| Recall event | 51708 |
| Product | Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota 55431., Mode of Operation: Operation with Intermittent/continuous load, Visible and Invisible LED Radiation, Class 3R LED Product, Refer to IEC 60825-2001 for further information., Input: 100 -230 V… |
| Product code | OHS |
| Recalling firm | Sybaritic, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2012 |
| FEI number | 2131125 |
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