Recall Z-0286-2008 ยท HQF Laser, Ophthalmic
Ellex USA
Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
| 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 | 10 |
| 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
| K041598 | LASEREX, MODEL LP4532 Ellex Medical Pty, Ltd., Oct 6, 2004 |