Device recall
Z-1419-06: LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
FDA device recall · Class II · Biocare Systems Inc.
Key facts
| Recall number (Z-number) | Z-1419-06 |
|---|---|
| Recall event | 35780 |
| Product | LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc. |
| Product code | ILY |
| Recalling firm | Biocare Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 3, 2011 |
| 510(k) numbers | K051816 |
| FEI number | 3005510978 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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