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Convergent Dental recalls Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Recalled October 30, 2013 · FDA recall Z-0050-2014 · Convergent Dental
Hazard
Specific error condition could lead to unintended laser emission during laser activation. · FDA Class II
Units
5
Sold at
US distribution including states of: MA, CT, NY.
Description
Specific error condition could lead to unintended laser emission during laser activation.
Product
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Manufacturer(s)
Convergent Dental
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →