FDA Recall
Terminated
TLC-2000 Therapeutic Medical Laser System
Recall: Z-1353-2020
·
Initiated September 26, 2019
Recall
- Recall Number
- Z-1353-2020
- Event Number
- 84844
- Firm
- Theralase Inc.
- FEI Number
- 3003614490
- Product Code
- NHN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 26, 2019
- Terminated
- December 3, 2020
- Address
- 41 Hollinger Rd, East York Canada
Description
TLC-2000 Therapeutic Medical Laser System
Reason
660 nm laser diodes may be below rated power output.
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 660 nm laser diodes will be analyzed and recalibrated / replaced, as required, to meet rated power output.
Distribution
USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Quantity
92 units