FDASeptember 26, 2019device

TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)

What to do

FDA enforcement status: Terminated

Brands named

theralase

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain. — Recall Details · AllClear