Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

TLC-2000 Therapeutic Medical Laser System Recalled by Theralase Inc. Due to Laser Probe (Model Number: TLC-2001) Electromagnetic Interference (...

Date: September 26, 2019
Company: Theralase Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Theralase Inc. directly.

Affected Products

TLC-2000 Therapeutic Medical Laser System

Quantity: 18 units

Why Was This Recalled?

Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard

Where Was This Sold?

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

About Theralase Inc.

Theralase Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report