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

Recall Z-1353-2020 — TLC-2000 Therapeutic Medical Laser System

U.S. FDA — Device Enforcement · Canada · 2019-09-26 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1353-2020
Date of alert
2019-09-26
Country / jurisdiction
Canada
Risk level
Class III
Risk type
recall
Brand
Theralase Inc.
Product category
device
Product type
Devices
Reported risk: 660 nm laser diodes may be below rated power output.
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.