Recall Z-1268-2016— Pelton & Crane / Marus / DCI Equipment / KaVo
Class II · Terminated
Class II FDA medical device recall by Pelton & Crane / Marus / DCI Equipment / KaVo, initiated 2016-03-08, terminated 2016-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Pelton & Crane / Marus / DCI Equipment / KaVo
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-08
- Terminated
- 2016-06-06
- Firm location
- Charlotte, NC, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.