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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 February 13, 2020
Recall Status1 Terminated 3 on December 03, 2020
Recall Number Z-1348-2020
Recall Event ID 84842
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, Model Number TLC-2002
Code Information Serial Numbers: 3104-3106 (inclusive); 3109 to 3141 (inclusive), 3143, 3146, 3147, 3155, 3158, 3159, 3163-3165 (inclusive), 3168-3173 (inclusive), 3180-3184 (inclusive), 3188-3332 (inclusive), 3334
Recalling Firm/
Manufacturer		 Theralase Inc.
41 Hollinger Rd
East York Canada
For Additional Information Contact Rishi Mehta
866-843-5273 Ext. 306
Manufacturer Reason
for Recall		 Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards
FDA Determined
Cause 2		 Process control
Action Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Please courier your TLC-2000 to Theralase, at your cost, for modification. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to your TLC-2000 Power Pack..
Quantity in Commerce 202 units
Distribution U.S.A.; 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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