FDAFDA · Food and drugs·Recall number Z-1326-2020
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Published February 26, 2020 · Recall initiated: September 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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)
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Theralase Inc.
- Distributor
- Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.
- Lot
- Serial Numbers: 3275 to 3350 (inclusive)
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Canada
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