🔍 RecallPedia

TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

Class I - Dangerous
🏥 Medical Devices Recalled: September 26, 2019 Theralase Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Theralase Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

Product Codes/Lot Numbers:

Serial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0607-2020

Related Recalls