Theralase TLC-2000 Laser System Recalled for Electromagnetic Interference Issues
Theralase Inc. is recalling 18 TLC-2000 Therapeutic Medical Laser Systems because the laser probes emit electromagnetic interference exceeding safety standards.
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 FDA classified this recall as Class III, which indicates a low risk of adverse health consequences, aligning with the 'Low' severity score in the rubric.
Plain-English summary
Theralase Inc. is recalling 18 units of the TLC-2000 Therapeutic Medical Laser System. The recall is due to the Laser Probe (Model Number: TLC-2001) emitting electromagnetic interference (EMI) that exceeds the IEC-60601-1-2 (4th edition) standard.
The affected units have serial numbers ranging from 3333 to 3350 (inclusive). These devices were distributed in 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 contact Theralase Inc. for instructions on how to address the electromagnetic interference issue.
The recalled product
- Product
- TLC-2000 Therapeutic Medical Laser System
- Manufacturer
- Theralase Inc.
- Category
- Medical Device — Laser Therapy
- Affected units
- 18
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: 3333 to 3350 (inclusive)
Distribution
Distribution scope not specified by the agency.
Related recalls
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