Device recall
Z-0940-2017: TVC Imaging System model TVC-MC9, for the near-infrared examination of coronary…
FDA device recall · Class II · Infraredx, Inc.
Key facts
| Recall number (Z-number) | Z-0940-2017 |
|---|---|
| Recall event | 76014 |
| Product | TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy… |
| Product code | OGZ |
| Recalling firm | Infraredx, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2018 |
| 510(k) numbers | K141682 |
| FEI number | 3015551113 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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