Device recall
Z-1539-2015: FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to…
FDA device recall · Class II · Therasage, LLC.
Key facts
| Recall number (Z-number) | Z-1539-2015 |
|---|---|
| Recall event | 70737 |
| Product | FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety . |
| Recalling firm | Therasage, LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2015 |
| FEI number | 3005893178 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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