Device recall
Z-0772-2020: There is a complaint regarding internal check cable guide mechanism failure for…
FDA device recall · Class II · Nucletron BV
Key facts
| Recall number (Z-number) | Z-0772-2020 |
|---|---|
| Recall event | 84371 |
| Product | There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause… |
| Product code | JAQ |
| Recalling firm | Nucletron BV |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2023 |
| 510(k) numbers | K070574 |
| FEI number | 3002807741 |
At a glance
- 1–9 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