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Terminated

TLC-2000 Therapeutic Medical Laser System

FDA Recall Z-1353-2020 · Posted None

Recalling FirmTheralase Inc.
Recall StatusTerminated
Product CodeNHN
Date Initiated2019-09-26
Date Terminated2020-12-03
Product Quantity92 units

Reason for Recall

660 nm laser diodes may be below rated power output.

Firm Action

Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase for analysis. Their 660 nm laser diodes will be analyzed and recalibrated / replaced, as required, to meet rated power output.

Root Cause

Device Design

Distribution Pattern

USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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