Device recall
Z-0803-2014: Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with…
FDA device recall · Class II · Civco Medical Instruments Inc
Key facts
| Recall number (Z-number) | Z-0803-2014 |
|---|---|
| Recall event | 66591 |
| Product | Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region. |
| Product code | IYE |
| Recalling firm | Civco Medical Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2017 |
| 510(k) numbers | K121545 |
| FEI number | 1937223 |
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