Laserex Systems Inc.: Medical Device Recall in 2016 - (Recall #: Z-1270-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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. .

Product Classification:

Class II

Date Initiated: February 1, 2016

Date Posted: April 13, 2016

Recall Number: Z-1270-2016

Event ID: 73468

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.

Status: Terminated

Product Quantity: 72 units plus 2 spare units

Code Information:

Model Number : 3143270

Distribution Pattern:

Worldwide Distribution - US Distribution

Voluntary or Mandated:

Voluntary: Firm initiated