Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002

Recall date

September 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1348-2020

FDA classification

Class III

Brand / firm

Theralase Inc.

Sold / distributed

U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Why it was recalled

Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002