| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00301-1 |
| Product Name/Description |
Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT)
Model Numbers: LP5532 and LR1532
Multiple Serial Numbers affected
ARTG Number: 106758 and 224484 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified a potential defect in the Fixed Laser Eye Safety Filter assembly for the above laser systems.
Under certain conditions there is potential for the glass of the safety filter optics to crack on their lower edge due to pressure applied on them by their retaining plate which in turn could damage the laser safety coating on the optics.
The safety filter is located on the binocular mount of the delivery head, and is in the user’s optical viewing path and as such provides protection to the user’s eyes from any diffused reflected laser light during the laser treatment.
There is a risk associated that if the above failure mode occurs, there is a remote possibility that during laser treatment the user could be exposed to any diffused reflected laser light. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ellex Medical is advising users to check the affected devices to see if there is any green laser light visible while firing the laser. If so, remove the device from use and notify Ellex. Ellex will be replacing the filters on all affected systems with a newly designed filter. This action has been closed-out on 27/01/2017. |
| Contact Information |
1800 800 180 - Ellex Service Hotline |