FDA recall Z-1353-2020
Theralase Inc. · Class III · device
Product
TLC-2000 Therapeutic Medical Laser System
Reason for recall
660 nm laser diodes may be below rated power output.
Distribution
USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania
Key facts
- Status
- Terminated
- Initiation date
- 2019-09-26
- Report date
- 2020-03-04
- Termination date
- 2020-12-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- East York, N/A, Canada
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1353-2020