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U.S. Department of Health and Human Services

Class 3 Device Recall Theralase

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  Class 3 Device Recall Theralase see related information
Date Initiated by Firm September 26, 2019
Date Posted December 05, 2019
Recall Status1 Terminated 3 on December 03, 2020
Recall Number Z-0607-2020
Recall Event ID 84168
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, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Code Information Serial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive.  Serial Number 3204 was sold abroad 
Recalling Firm/
Manufacturer		 Theralase Inc.
41 Hollinger Rd
East York Canada
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 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.
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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