Recall Z-1266-2020 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 | Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard |
| 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. The TLC-2000 will be updated to reduce EMI to meet IEC 60601-1-2 standard (4th edition). |
| Quantity | 18 units |
| Distribution | 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 |