Device recall
Z-2244-2016: Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD…
FDA device recall · Class II · Bayer Healthcare
Key facts
| Recall number (Z-number) | Z-2244-2016 |
|---|---|
| Recall event | 74513 |
| Product | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to… |
| Product code | DXT |
| Recalling firm | Bayer Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2016 |
| 510(k) numbers | K143538 |
| 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