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Terminated

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

FDA Recall Z-0606-2020 · Posted 2019-12-05

Recalling FirmTheralase Inc.
Recall StatusTerminated
Product CodeNHN
Date Initiated2019-09-26
Date Terminated2020-12-03
Product Quantity41 units

Reason for Recall

Device was shipped without a Unique Device Identification (UDI) label.

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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