Z-1270-2016 Class II Terminated
FDA device recall Z-1270-2016 was initiated by Laserex Systems Inc. on February 1, 2016 and is designated Class II. 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. The recall status is terminated (terminated October 27, 2016). Affected quantity: 72 units plus 2 spare units.
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