Z-1353-2020 Class III Terminated

Recalled by Theralase Inc. — East York, N/A

Recall Details

Product Type
Devices
Report Date
March 4, 2020
Initiation Date
September 26, 2019
Termination Date
December 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
92 units

Product Description

TLC-2000 Therapeutic Medical Laser System

Reason for Recall

660 nm laser diodes may be below rated power output.

Distribution Pattern

USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Code Information

Serial Numbers: 3245 to 3336 (inclusive)