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Topcon Medical Laser Systems, Inc recalls PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Recalled July 31, 2013 · FDA recall Z-1774-2013 · Topcon Medical Laser Systems
Hazard
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment. · FDA Class II
Units
7 US, 33 foreign
Sold at
Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
Description
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
Product
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Manufacturer(s)
Topcon Medical Laser Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →