Theralase recalls TLC-2000 Therapeutic Medical Laser System Power Packs (Model TLC-2002) with serial numbers 3104-3106, 3109-3141, etc. due to missing safety testing. Affected users should contact Theralase for details.
Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards
Theralase is recalling specific models of their TLC-2000 Therapeutic Medical Laser System Power Packs because they were not tested to a required safety standard. This could pose a risk if the device is used improperly, but the recall does not indicate immediate danger to users.
The power pack was shipped without testing to IEC-60601-1-2 (3rd edition) safety standards, which are required for medical devices. This could mean the device might not function safely under certain conditions, but the risk is not described as immediate or severe.
Medical professionals using the TLC-2000 system with the recalled power packs are most at risk. The recall affects specific serial numbers of the power packs.
Check the serial number on the power pack. The affected models have serial numbers from 3104-3106, 3109-3141, 3143, 3146, 3147, 3155, 3158, 3159, 3163-3165, 3168-3173, 3180-3184, 3188-3332, and 3334.
Look for the serial number on the power pack to determine if it is affected.
The power pack was not tested to IEC-60601-1-2 (3rd edition) safety standards, which are required for medical devices.
Check the serial number to see if it is affected. If it is, contact Theralase for further instructions.
The recall states the power pack was not tested to a required safety standard, but it does not describe a specific risk of injury.
We’ve drafted a message you can send Theralase to request your refund or repair — edit it as you like.
Subject: Recall Z-1348-2020 — Theralase Theralase Hello, I own a Theralase that is covered by recall Z-1348-2020 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.
