Theralase recalls TLC-2000 Therapeutic Medical Laser Power Packs (serials 3012-3350) due to missing CE Mark label. This could cause regulatory issues but not immediate safety risks.
Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
Theralase is recalling specific models of their knee pain laser power packs because they were shipped without a required CE Mark label. This means the device might not meet European safety standards, but it does not pose an immediate risk of injury.
The power packs were shipped without a Unique Device Identification (UDI) label and the CE Mark label indicates the device has not yet received European approval. This means the device may not meet European safety standards, but it does not cause immediate physical harm.
Users of the TLC-2000 Therapeutic Medical Laser System power packs with serial numbers 3012 to 3350 are affected. People using these devices for knee pain relief are most at risk of regulatory non-compliance.
Check the serial number on the TLC-2002 Power Pack. Serial numbers 3012 to 3204 and 3202 to 3350 are affected. Note that serial number 3204 was sold abroad.
Look for the serial number on the TLC-2002 Power Pack. Affected units have serial numbers 3012 to 3204 or 3202 to 3350.
The power packs were shipped without a required Unique Device Identification (UDI) label and the CE Mark label indicates the device has not yet received European approval.
Check the serial number on the power pack. If it is between 3012 and 3204 or 3202 and 3350, contact Theralase for guidance.
No, the recall is for regulatory compliance, not safety risks. The device does not pose an immediate 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-0607-2020 — Theralase Theralase Hello, I own a Theralase that is covered by recall Z-0607-2020 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.
