Device recall
Z-0762-2020: iMRX MRI and Angiography System, part number 10094137 and 10094141, a…
FDA device recall · Class II · Deerfield Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-0762-2020 |
|---|---|
| Recall event | 84400 |
| Product | iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The… |
| Product code | LNH |
| Recalling firm | Deerfield Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2020 |
| 510(k) numbers | K101813 |
| 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