Recall Z-1354-2020 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
| Date | Feb 13, 2020 (initiated Sep 26, 2019) |
| Status | Terminated |
| Reason | 905 nm laser diodes may be below rated power output. |
| Root cause | Device Design |
| 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 for analysis. Their 905 nm laser diodes will be analyzed and recalibrated, as required, to meet rated power output. |
| Quantity | 92 units |
| Distribution | USA; 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 |