Device recall
Z-1645-2018: IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI…
FDA device recall · Class II · Deerfield Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-1645-2018 |
|---|---|
| Recall event | 79816 |
| Product | IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use. |
| Product code | LNH |
| Recalling firm | Deerfield Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2020 |
| 510(k) numbers | K133692 |
| FEI number | 3010326005 |
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