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…

Recall date

September 1, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0324-2024

FDA classification

Class II

Brand / firm

Convergent Dental

Sold / distributed

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.

Why it was recalled

It has been found that potential unintended laser activation can occur without foot pedal depression.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked