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

FDA device recall Z-0607-2020 · posted 2019-12-05 · Terminated

Recall details

Recalling firm

Theralase Inc.

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.

Action taken

On September 26, 2019 the firm distributed Urgent Medical Device Recall Communication letters. Check the Serial Number on your TLC-2000 Power Pack (Model Number: TLC-2002) to see if your TLC-2000 is affected by the following issues: 1) The TLC-2000 Power Pack was shipped with a label identifying it as being CE compliant. What Should You Do?: No action required. The TLC-2000 is approved for sale in Canada under Medical Device License Number: 98357. The TLC-2000 is cleared for sale in the United States by the FDA under 510(k) number: K151816. *Product with Serial Number 3204 was sold in the European Union. Only the owner of Serial Number 3204 should return their TLC-2000. 2)The TLC-2000 was shipped without a Unique Device Identification (UDI) label. What Should You Do?: Please courier your TLC-2000 to Theralase, at your cost, for update. A UDI label will be added to your TLC-2000, at no charge and your TLC-2000 will be couriered back to you at Theralase's cost.

Root cause

Process control

Status

Terminated

Product code

NHN

Quantity affected

306 units

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.

Date initiated

2019-09-26

Date posted

2019-12-05

Date terminated

2020-12-03

Location

East York, Canada

Related 510(k) clearances