| Class 3 Device Recall Theralase | |
Date Initiated by Firm | September 26, 2019 |
Date Posted | December 05, 2019 |
Recall Status1 |
Terminated 3 on December 03, 2020 |
Recall Number | Z-0606-2020 |
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
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Product | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. |
Code Information |
Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129, 3131, 3132, 3137, 3139, 3155, 3162, 3166, 3171, 3183, 3187, 3200, 3206, 3227, 3245, 3266, 3268, 3293, 3296, 3297, 3305, 3308, 3318, 3321, 3332 |
Recalling Firm/ Manufacturer |
Theralase Inc. 41 Hollinger Rd East York Canada
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Manufacturer Reason for Recall | Device was shipped without a Unique Device Identification (UDI) label. |
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 | 41 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 |
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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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