Device recall
Z-0675-06: her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile…
FDA device recall · Class II · American Medical Systems
Key facts
| Recall number (Z-number) | Z-0675-06 |
|---|---|
| Recall event | 34426 |
| Product | her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe. |
| Product code | MNB |
| Recalling firm | American Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2008 |
| PMA numbers | P000032 |
| FEI number | 1000116179 |
At a glance
- None 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