Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1270-2016 — 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. .

U.S. FDA — Device Enforcement · United States · 2016-02-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1270-2016
Date of alert: 2016-02-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Laserex Systems Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1270-2016 — 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. .

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