Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System
- Recall date
- September 26, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1266-2020
- FDA classification
- Class III
- Brand / firm
- Theralase Inc.
- Sold / distributed
- Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Why it was recalled
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
TLC-2000 Therapeutic Medical Laser System
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