FDAFebruary 1, 2016device
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. .
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
laserex systemslaserex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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