Device recall
Z-2733-2014: Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser…
FDA device recall · Class II · Lumenis, Inc.
Key facts
| Recall number (Z-number) | Z-2733-2014 |
|---|---|
| Recall event | 69139 |
| Product | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and… |
| Product code | HQF |
| Recalling firm | Lumenis, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2014 |
| 510(k) numbers | K130195 |
| FEI number | 1720381 |
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