FDAMarch 8, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

pelton crane marus dci equipment kavopeltonpelton crane

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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