Device recall
Z-0970-2019: C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The…
FDA device recall · Class II · PENTAX of America Inc
Key facts
| Recall number (Z-number) | Z-0970-2019 |
|---|---|
| Recall event | 81695 |
| Product | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. |
| Product code | GEH |
| Recalling firm | PENTAX of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| 510(k) numbers | K163684 |
| FEI number | 3008780134 |
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