Device recall
Z-2109-2018: 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C…
FDA device recall · Class II · Ion Beam Applications S.A.
Key facts
| Recall number (Z-number) | Z-2109-2018 |
|---|---|
| Recall event | 80219 |
| Product | 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system. |
| Product code | LHN |
| Recalling firm | Ion Beam Applications S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 9, 2019 |
| 510(k) numbers | K132847 |
| FEI number | 3000256071 |
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