Device recall
Z-2775-2015: Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes…
FDA device recall · Class II · Bayer Healthcare
Key facts
| Recall number (Z-number) | Z-2775-2015 |
|---|---|
| Recall event | 71994 |
| Product | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. |
| Product code | DXT |
| Recalling firm | Bayer Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 17, 2016 |
| 510(k) numbers | K132928 |
| FEI number | 2520313 |
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