| Class 3 Device Recall Theralase TLC2000 | |
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
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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/ Manufacturer |
Theralase Inc. 41 Hollinger Rd East York Canada
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NHN
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