Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The… — Class II medical device recall Z-1268-2016
Terminated recall by Pelton & Crane / Marus / DCI Equipment / KaVo, reported 2016-04-06, distributed nationwide. The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted
| Recall number | Z-1268-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pelton & Crane / Marus / DCI Equipment / KaVo, Charlotte, NC, United States |
| Recall initiated | 2016-03-08 |
| Classified | 2016-03-28 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2016-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 156 units |
| Serial numbers | 11099, 11100, 11101, 11102, 11103, 11104, 11105, 11106, 11107, 11108, 11109, 11111, 11112, 11113, 11114, 11115, 11116, 11117, 11118, 11119, 11120, 11121, 11122, 11123, 11124 and 131 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1268-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.