Medical device recalls

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-1353-2020
FDA classification
Class III
Brand / firm
Theralase Inc.
Sold / distributed
USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Why it was recalled

660 nm laser diodes may be below rated power output.

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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