Z-2191-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2013
- Initiation Date
- August 19, 2013
- Termination Date
- December 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
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.
Distribution Pattern
Distributed in the states of NJ, PA, and IL.
Code Information
Model: GA-0025020