Z-1270-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2016
- Initiation Date
- February 1, 2016
- Termination Date
- October 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 units plus 2 spare units
Product Description
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
Reason for Recall
The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
Distribution Pattern
Worldwide Distribution - US Distribution
Code Information
Model Number : 3143270