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

Recall Z-2172-2017 — Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture

U.S. FDA — Device Enforcement · United States · 2017-04-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2172-2017
Date of alert: 2017-04-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Laserex Systems Inc.
Product category: device
Product type: Devices

Reported risk: It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

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