Device recall
Z-0693-2013: Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument…
FDA device recall · Class II · Quanta System, S.p.A.
Key facts
| Recall number (Z-number) | Z-0693-2013 |
|---|---|
| Recall event | 64039 |
| Product | Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis; Treatment of benign… |
| Product code | GEX |
| Recalling firm | Quanta System, S.p.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2013 |
| 510(k) numbers | K070805, K083207 |
| FEI number | 3004378299 |
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