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Laserex Systems Inc. recalls Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the l
Recalled April 13, 2016 · FDA recall Z-1270-2016 · Laserex Systems
Hazard
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. · FDA Class II
Units
72 units plus 2 spare units
Sold at
Worldwide Distribution - US Distribution
Description
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.
Product
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. .
Manufacturer(s)
Laserex Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →