Theralase TLC-2000 Laser System Recall: Electromagnetic Interference Risk

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Recalling firmTheralase Inc.41 Hollinger Rd · East York, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Theralase is recalling TLC-2000 Therapeutic Medical Laser Systems with serial numbers 3333 to 3350 because they may cause electromagnetic interference that could affect other medical devices. This could lead to potential safety issues during medical treatments.

Why it’s dangerous

The laser probe (model TLC-2001) in the system may emit electromagnetic interference that exceeds the IEC-60601-1-2 (4th edition) safety standard. This interference could potentially disrupt other medical devices during use, though the risk is not severe.

Who’s affected

Medical professionals using the TLC-2000 system with serial numbers 3333 to 3350 are most at risk. Patients receiving treatments with this equipment may also be affected.

How to tell if you have this one

Check if your TLC-2000 system has a serial number between 3333 and 3350 inclusive. The laser probe model number is TLC-2001.

Brand
Theralase
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify your TLC-2000 system's serial number to see if it falls between 3333 and 3350.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall is for electromagnetic interference that may affect other medical devices, but the risk is low and not severe.

What should I do if I have this product?

Check your serial number; if it's between 3333 and 3350, contact Theralase for further instructions.

How can I tell if my laser probe is affected?

The affected laser probe model number is TLC-2001. Check your product's model number.

Take action

Contact Theralase

We’ve drafted a message you can send Theralase to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1266-2020 — Theralase Theralase

Hello,

I own a Theralase that is covered by recall Z-1266-2020 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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Where this comes from

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.

Official source: FDA Recall #Z-1266-2020 (September 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1266-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Theralase Inc. recalls TLC-2000 Therapeutic Medical Laser System

Lower-risk recall