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Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System
Recalled February 26, 2020 · FDA recall Z-1266-2020 · Theralase
Hazard
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard · FDA Class III
Units
18 units
Sold at
Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Description
Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
Product
TLC-2000 Therapeutic Medical Laser System
Manufacturer(s)
Theralase Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →