Device recall
Z-0428-2013: IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are…
FDA device recall · Class II · Innovative Magnetic Resonance Imaging Systems Inc.
Key facts
| Recall number (Z-number) | Z-0428-2013 |
|---|---|
| Recall event | 63500 |
| Product | IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems. |
| Product code | LNH |
| Recalling firm | Innovative Magnetic Resonance Imaging Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2012 |
| 510(k) numbers | K061916, K071099, K083137 |
| FEI number | 3003807210 |
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