Recall Z-1326-2020 ยท NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Theralase Inc.
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
| Date | Feb 13, 2020 (initiated Sep 26, 2019) |
| Status | Terminated |
| Reason | 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) |
| Root cause | 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 | 76 units |
| Distribution | Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151816 | TLC-2000 Therapeutic Medical Laser System Theralase, Inc., Nov 19, 2015 |