Device recall
Z-0362-2020: TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse…
FDA device recall · Class II · Tec Com Gmbh
Key facts
| Recall number (Z-number) | Z-0362-2020 |
|---|---|
| Recall event | 83707 |
| Product | TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient… |
| Product code | DWJ |
| Recalling firm | Tec Com Gmbh |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 20, 2019 |
| 510(k) numbers | K140078 |
| FEI number | 3011097288 |
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