Theralase TLC-2000 Laser System Recalled for Low Power Output
Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 660 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 source text explicitly states the agency classification is Class III. Per the rubric, FDA Class III recalls are typically scored as 1 or 2 because they are by definition unlikely to cause adverse health consequences.
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 660 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 internationally to Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, the Philippines, Thailand, and Romania.
The U.S. Food and Drug Administration classifies this as a Class III recall. 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.
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