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U.S. Department of Health and Human Services

Class 3 Device Recall Theralase TLC2000

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  Class 3 Device Recall Theralase TLC2000 see related information
Date Initiated by Firm September 26, 2019
Date Posted February 13, 2020
Recall Status1 Terminated 3 on December 03, 2020
Recall Number Z-1326-2020
Recall Event ID 84845
510(K)Number K151816  
Product Classification Powered Light Based Laser Non-Thermal Instrument with Non-Heating Effect For Adjunctive Use in Pain Therapy - Product Code NHN
Product TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Code Information Serial Numbers: 3275 to 3350 (inclusive)
Recalling Firm/
Theralase Inc.
41 Hollinger Rd
East York Canada
For Additional Information Contact Rishi Mehta
866-843-5273 Ext. 306
Manufacturer Reason
for Recall
Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)
FDA Determined
Cause 2
Process control
Action Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Healthcare practitioners are instructed to courier their TLC-2000 to Theralase. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to the TLC-2000.The Field Inspection Test will be completed according to either CSA 60601-1 or UL 60601-1 dependent upon the customers Canadian or United States location, respectively.
Quantity in Commerce 76 units
Distribution Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NHN and Original Applicant = Theralase Inc.