Theralase recalls TLC-2000 laser systems with serial numbers 3275-3350 due to power supply mismatch. This mismatch may cause malfunction but does not pose immediate injury risk.
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)
Theralase is recalling TLC-2000 therapeutic laser systems for knee pain relief that have serial numbers 3275 to 3350. The recall is due to a power supply model mismatch that could cause malfunction, but it does not pose a risk of serious injury.
The power supply model in the recalled units (TLC-2003 ME90A2403F01) has different specifications than the required model (TLC-2003 MENB1100A2403F01). This mismatch could cause the device to malfunction, but it does not cause immediate injury.
People who own or use the TLC-2000 laser system with serial numbers 3275 to 3350 are affected. Those using the device for knee pain relief are most at risk.
Check the serial number on the device, which ranges from 3275 to 3350 inclusive. The product is a TLC-2000 Therapeutic Medical Laser System used for temporary knee pain relief.
Look for the serial number on the device, which should be between 3275 and 3350 inclusive.
The power supply model in the recalled units (TLC-2003 ME90A2403F01) has different specifications than the required model (TLC-2003 MENB1100A2403F01), which could cause malfunction.
No, the recall does not indicate a risk of serious injury. The hazard is a potential malfunction but not an immediate safety risk.
Check the serial number on the device; affected units have serial numbers from 3275 to 3350 inclusive.
We’ve drafted a message you can send Theralase to request your refund or repair — edit it as you like.
Subject: Recall Z-1326-2020 — Theralase Theralase Hello, I own a Theralase that is covered by recall Z-1326-2020 from Theralase. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
