Device recall
Z-0671-2018: Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0…
FDA device recall · Class II · Med Tec Inc
Key facts
| Recall number (Z-number) | Z-0671-2018 |
|---|---|
| Recall event | 79182 |
| Product | Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and… |
| Product code | JAI |
| Recalling firm | Med Tec Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| 510(k) numbers | K132084 |
| FEI number | 1000143606 |
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