Recall Z-1348-2020 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 Power Pack, Model Number TLC-2002
| Date | Feb 13, 2020 (initiated Sep 26, 2019) |
| Status | Terminated |
| Reason | Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards |
| Root cause | Process control |
| Action | Email was sent out to healthcare practitioners regarding the recall on September 26, 2019. Please courier your TLC-2000 to Theralase, at your cost, for modification. A Field Inspection Test will be completed and once passed, a Special Inspections for Medical Electrical Equipment and Systems label will be applied to your TLC-2000 Power Pack.. |
| Quantity | 202 units |
| Distribution | U.S.A.; 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 |