Device recall
Z-1874-2013: MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option…
FDA device recall · Class I · Iradimed Corporation
Key facts
| Recall number (Z-number) | Z-1874-2013 |
|---|---|
| Recall event | 65778 |
| Product | MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or… |
| Product code | FRN |
| Recalling firm | Iradimed Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 13, 2015 |
| 510(k) numbers | K090087 |
| FEI number | 3005053560 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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