Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model: GA-0025020
- 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:
- Lumenis, Inc.
- Reason for Recall:
- Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Product Codes/Lot Numbers:
Model: GA-0025020
Distribution:
Distributed in: NJ, PA, IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2191-2013
Related Recalls
The potential for unsterilized product within finished product labeled as sterile.
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.
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