Recall Z-0577-2010 ยท HQF Laser, Ophthalmic
Ellex Medical Pty Ltd
Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.
| Date | Jan 20, 2010 (initiated Feb 11, 2009) |
| Status | Terminated |
| Reason | Potential for two screws important in the design of the safety filter to come loose. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Ellex issued a bulletin stating the problem and identifying the affected products. Customers are to remove the Motorised Safety Filter from clinical use if the green laser light is visible while viewing through the microscope at any time during use of the Solitaire laser. The Bulletin also states that customers should contact an Ellex approved Service Engineer to investigate and perform the Field Corrective Action listed. The manufacturer will remedy the defect or bring the product into compliance free of charge. Ellex will inspect and rework all affected safety filters sold prior to Febru |
| Quantity | 200 units total |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.