Recall Z-0287-2008 ยท HQF Laser, Ophthalmic
Ellex USA
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. )
| Date | Dec 20, 2007 (initiated Jun 13, 2007) |
| Status | Terminated |
| Reason | Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user. |
| Root cause | Device Design |
| Action | Ellex, Inc. called each customer on 6/13/07, about the problem (defect which can cause electric shock) and advised that they would be performing modification of the power supply in the laser system and scheduling a field service visit to complete the work. Upon completion of the modification, the service technician completed the service record and left a copy with each client and informed them of the completed work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by service t |
| Quantity | 1 |
| Distribution | Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052777 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D Ellex Medical Pty, Ltd., Mar 16, 2006 |