Home / Recalls / Medical Devices
Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System
Recalled March 4, 2020 · FDA recall Z-1353-2020 · Theralase
Hazard
660 nm laser diodes may be below rated power output. · FDA Class III
Units
92 units
Sold at
USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Description
660 nm laser diodes may be below rated power output.
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 →