FDA recall Z-0607-2020

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-09-26

Report date

2019-12-11

Termination date

2020-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

East York, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0607-2020