Recall Z-1326-2020— Theralase Inc.
Class III · Terminated
Class III FDA medical device recall by Theralase Inc., initiated 2019-09-26, terminated 2020-12-03. It names one FDA 510(k) clearance: K151816. Product: TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.. Reason: 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).
- Recalling firm
- Theralase Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-09-26
- Terminated
- 2020-12-03
- Firm location
- East York, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.