Theralase recalls TLC-2:000 Therapeutic Medical Laser Systems with serial numbers 3245-3336 due to potential low laser power output. Affected units may not function as intended.
660 nm laser diodes may be below rated power output.
Theralase is recalling TLC-2000 Therapeutic Medical Laser Systems with serial numbers 3245 to 3336 because the laser diodes might not be producing the rated power. This could mean the device doesn't work properly for medical treatments.
The laser diodes in these devices might not be producing the required power level. This could lead to the device not working properly during medical treatments, potentially affecting treatment effectiveness.
Medical professionals using the TLC-2000 laser systems with serial numbers 3245 to 3336 are affected. Patients receiving treatments from these devices may be at risk if the laser doesn't function as intended.
Check the serial number on your TLC-2000 Therapeutic Medical Laser System. Affected units have serial numbers from 3245 to 3336 inclusive.
Identify the serial number on your device to see if it falls within 3245 to 3336.
The laser diodes may not be producing the rated power output, which could affect the device's medical functionality.
Check the serial number to see if it's in the range 3245 to 3336. If so, contact Theralase for guidance.
The recall record does not mention a specific remedy or fix.
We’ve drafted a message you can send Theralase to request your refund or repair — edit it as you like.
Subject: Recall Z-1353-2020 — Theralase Theralase Hello, I own a Theralase that is covered by recall Z-1353-2020 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.
