Device recall
Z-0822-2013: Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and…
FDA device recall · Class II · Viterion TeleHealthcare Llc
Key facts
| Recall number (Z-number) | Z-0822-2013 |
|---|---|
| Recall event | 64111 |
| Product | Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information. |
| Product code | MWI |
| Recalling firm | Viterion TeleHealthcare Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 16, 2017 |
| 510(k) numbers | K004050 |
| FEI number | 3003962513 |
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