Pelton & Crane / Marus / DCI Equipment / KaVo recalls Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals…

Recall date

March 8, 2016

Source

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

Recall number

Z-1268-2016

FDA classification

Class II

Brand / firm

Pelton & Crane / Marus / DCI Equipment / KaVo

Sold / distributed

US Nationwide Distribution in the states of AZ, AR, CA, CO, CT, FL, IA, ID, IL, IN, MA, MI, MN, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, WI and Canada

Why it was recalled

The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation of the dental light.

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

What was recalled

Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.