Recall Z-1270-2016— Laserex Systems Inc.

Name: FDA recall Z-1270-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-01

Class II · Terminated

Class II FDA medical device recall by Laserex Systems Inc., initiated 2016-02-01, terminated 2016-10-27. It names one FDA 510(k) clearance: K052777. 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. .. Reason: 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..

Recalling firm: Laserex Systems Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-01
Terminated: 2016-10-27
Firm location: EDEN PRAIRIE, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K052777 — LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-DEllex Medical Pty, Ltd.·cleared 2006-03-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.