The Recall Desk
LowFDA (Devices)·Z-1354-2020·Announced 2020-03-04

Theralase TLC-2000 Laser System Recalled for Low Power Output

Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 905 nm laser diodes may be below rated power output.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The defect involves lower-than-rated power output rather than a direct safety hazard like fire or shock.

Plain-English summary

Theralase Inc. is recalling 92 units of the TLC-2000 Therapeutic Medical Laser System. The recall is due to a defect where the 905 nm laser diodes may be below rated power output.

The affected units have serial numbers ranging from 3245 to 3336 inclusive. These devices were distributed in the United States and in several international locations, including Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, and Romania.

The U.S. Food and Drug Administration has classified this recall as Class III. Consumers and healthcare providers should stop using the affected devices and contact Theralase Inc. for instructions on how to proceed.

The recalled product

Product
TLC-2000 Therapeutic Medical Laser System
Manufacturer
Theralase Inc.
Category
Medical Device — Laser Therapy
Hazard
Affected units
92

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: 3245 to 3336 inclusive

Distribution

Distribution scope not specified by the agency.

Related recalls

Same manufacturer · Theralase Inc.

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