Z-1326-2020 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- September 26, 2019
- Termination Date
- December 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 units
Product Description
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Reason for Recall
Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)
Distribution Pattern
Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.
Code Information
Serial Numbers: 3275 to 3350 (inclusive)