Device recall
Z-1264-2016: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast…
FDA device recall · Class II · Wfr/aquaplast Corp
Key facts
| Recall number (Z-number) | Z-1264-2016 |
|---|---|
| Recall event | 73543 |
| Product | Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for… |
| Product code | IYE |
| Recalling firm | Wfr/aquaplast Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 6, 2017 |
| 510(k) numbers | K090349 |
| FEI number | 1000208827 |
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