DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product including the 2
FDA device recall Z-1602-2009 · posted 2009-07-13 · Terminated
Recall details
- Recalling firm
- Sybaritic, Inc
- Reason for recall
- A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan failure which resulted in the overheating and failure of the IR emitter and surrounding assembly.
- Action taken
- Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered. For further questions, contact Sybaritic, Inc. at 1-800-445-8418.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IMB
- Quantity affected
- 238 units
- Distribution
- Worldwide Distribution -- US including states of CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, A
- Date initiated
- 2007-06-22
- Date posted
- 2009-07-13
- Date terminated
- 2012-07-05
- Location
- Bloomington, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM (K003916) | Scandia Manufacturing , Ltd. | 2002-04-15 |