Theralase Inc. Recalls TLC-2000 Therapeutic Medical Laser Systems
Theralase Inc. is recalling 76 TLC-2000 laser systems because they were shipped with an incorrect power supply model.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 by definition is unlikely to cause adverse health consequences. The issue involves a component specification discrepancy without reported injuries.
Plain-English summary
Theralase Inc. is recalling 76 units of the TLC-2000 Therapeutic Medical Laser System. The product is indicated for the temporary relief of knee pain. The recall involves serial numbers 3275 to 3350 (inclusive).
The recall was initiated because the units were shipped with a Power Supply Model Number TLC-2003 ME90A2403F01 (24 VDC, 3.75 A, 90 W) instead of the specified Power Supply Model Number TLC-2003 MENB1100A2403F01 (24 VDC, 4.2 A, 101 W). Both power supply models meet UL/EN/IEC-60601-1-2 specifications, but the shipped model corresponds to the 4th edition specification while the specified model corresponds to the 3rd edition.
The affected units were distributed worldwide, including the United States, Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, and Romania. Consumers should contact Theralase Inc. for further instructions regarding the recall.
The recalled product
- Product
- TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
- Manufacturer
- Theralase Inc.
- Hazard
- Affected units
- 76
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: 3275 to 3350 (inclusive)
Distribution
Distributed nationwide across the United States.
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