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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall 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-1266-2020
Recall Event ID 84846
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
Code Information Serial Numbers: 3333 to 3350 (inclusive)
Recalling Firm/
Manufacturer		 Theralase Inc.
41 Hollinger Rd
East York Canada
Manufacturer Reason
for Recall		 Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard
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. The TLC-2000 will be updated to reduce EMI to meet IEC 60601-1-2 standard (4th edition).
Quantity in Commerce 18 units
Distribution 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.
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