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Terminated

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

FDA Recall Z-1326-2020 · Posted 2020-02-13

Recalling FirmTheralase Inc.
Recall StatusTerminated
Product CodeNHN
Date Initiated2019-09-26
Date Terminated2020-12-03
Product Quantity76 units

Reason for Recall

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)

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. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to the TLC-2000.The Field Inspection Test will be completed according to either CSA 60601-1 or UL 60601-1 dependent upon the customers Canadian or United States location, respectively.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and countries 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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