Device recall
Z-0287-2008: Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street…
FDA device recall · Class II · Ellex USA
Key facts
| Recall number (Z-number) | Z-0287-2008 |
|---|---|
| Recall event | 45499 |
| Product | Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. ) |
| Product code | HQF |
| Recalling firm | Ellex USA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2008 |
| 510(k) numbers | K052777 |
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