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Convergent Dental recalls Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K rewo
Recalled November 29, 2023 · FDA recall Z-0324-2024 · Convergent Dental
Hazard
It has been found that potential unintended laser activation can occur without foot pedal depression. · FDA Class II
Units
39 units
Sold at
Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.
Description
It has been found that potential unintended laser activation can occur without foot pedal depression.
Product
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Manufacturer(s)
Convergent Dental
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →