Laserex Systems Inc. recalls Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the lase…

Recall date

February 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1270-2016

FDA classification

Class II

Brand / firm

Laserex Systems Inc.

Sold / distributed

Worldwide Distribution - US Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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. .