Device recall
Z-1036-2012: Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No…
FDA device recall · Class II · Viterion TeleHealthcare Llc
Key facts
| Recall number (Z-number) | Z-1036-2012 |
|---|---|
| Recall event | 60946 |
| Product | Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor… |
| Product code | MWI |
| Recalling firm | Viterion TeleHealthcare Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2018 |
| FEI number | 3003962513 |
At a glance
- None 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