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Terminated

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.

FDA Recall Z-1268-2016 · Posted None

Recalling FirmPelton & Crane / Marus / DCI Equipment / KaVo
Recall StatusTerminated
Product CodeEAZ
Date Initiated2016-03-08
Date Terminated2016-06-06
Product Quantity156 units

Reason for Recall

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.

Firm Action

Pelton & Crane sent an Urgent Medical Device Recall letters to affected customers on March 8, 2016 and will be completed by 3/11/2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Acknowledgement Form in the enclosed self-address stamped envelope to Pelton & Crane. For questions or concerns regarding this recall please call 1-800-659-6560, ext. 7227.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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