Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

Recall date

September 26, 2019

Source

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

Recall number

Z-0607-2020

FDA classification

Class III

Brand / firm

Theralase Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.

Why it was recalled

Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.

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 component TLC-2002 Used for the temporary relief of knee pain.