Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.

Class I - Dangerous

🏥 Medical Devices Recalled: February 19, 2013 Trumpf Medical Systems Other Medical Devices

What Should You Do?

Check if you have this product:
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Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Trumpf Medical Systems, Inc.
Reason for Recall:: Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.

Product Codes/Lot Numbers:

Unknown

Distribution:

Distributed in: US, AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0484-2014

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