Device recall
Z-0646-2019: IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product…
FDA device recall · Class II · Deerfield Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-0646-2019 |
|---|---|
| Recall event | 81574 |
| Product | IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum… |
| Product code | FQO |
| Recalling firm | Deerfield Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2021 |
| FEI number | 3010326005 |
At a glance
- None 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