FDAFDA · Food and drugs·Recall number Z-2191-2013
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Published September 18, 2013 · Recall initiated: August 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lumenis, Inc.
- Distributor
- Distributed in the states of NJ, PA, and IL.
- Lot
- Model: GA-0025020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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