FDA recall Z-1266-2020

Theralase Inc. · Class III · device

Product

TLC-2000 Therapeutic Medical Laser System

Reason for recall

Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard

Distribution

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
2020-02-26
Termination date
2020-12-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
East York, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1266-2020