Device recall
Z-1604-2009: DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is…
FDA device recall · Class II · Sybaritic, Inc
Key facts
| Recall number (Z-number) | Z-1604-2009 |
|---|---|
| Recall event | 52036 |
| Product | DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. Part #E30008 - Spa-Oceana 2G;220V,50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as… |
| Product code | IMB |
| Recalling firm | Sybaritic, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2012 |
| 510(k) numbers | K003916 |
| FEI number | 2131125 |
At a glance
- 1–9 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