Device recall
Z-1400-2010: V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a…
FDA device recall · Class II · Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.
Key facts
| Recall number (Z-number) | Z-1400-2010 |
|---|---|
| Recall event | 54004 |
| Product | V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue. |
| Product code | GEH |
| Recalling firm | Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2010 |
| 510(k) numbers | K011074, K023757, K060279 |
| FEI number | 3008262715 |
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