Z-1268-2016Class II

Helios HL3T and HLT Track Mounted Dental Lights

Name: Z-1268-2016 Helios HL3T and HLT Track Mounted Dental Lights
Creator: Pelton & Crane / Marus / DCI Equipment / KaVo
Published: 2016-03-08
License: https://open.fda.gov/license/

KaVo Dental Technologies, LLC / initiated 2016-03-08 / Terminated / root cause: manufacturing process

FDA source

Pelton & Crane / Marus / DCI Equipment / KaVo began a recall of 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... on 2016-03-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1268-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-08
Posted: 2016-03-28
Terminated: 2016-06-06
Recalling firm: KaVo Dental Technologies, LLC
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.
Product code: EAZ Light, Operating, Dental
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 156 units
Distribution: 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
Product codes and lots: Model/Serial No. - HLT-5535, 5543, 5536, 5537, 5538, 5556, 5540, 5541, 5545, 5546, 5515, 5500, 5503, 5520, 5521, 5547, 5548, 5549, 5550, 5551, 5552, 5510, 5558, 5522, 5523, 5524, 5525, 5526, 5527, 5528, 5529, 5530, 5531, 5532, 5501, 5502, 5504, 5505, 5534, 5508, 5509, 5533, 5516, 5517, 5518, 5519, 5544, 5553, 5554, 5555, 5542, 5557, 5506, 5507, 5511, 5498, 5539, 5499, 5512, 5513, 5514; Model/Serial No. HL3T-11110, 11102, 11103, 11104, 11105, 11106, 11099, 11164, 11165, 11166, 11167, 11193, 11170, 11171, 11118, 11119, 11120, 11145, 11146, 11147, 11148, 11149, 11121, 11123, 11150, 11113, 11114, 11115, 11116, 11117, 11168, 11169, 11158, 11187, 11133, 11144, 11136, 11137, 11138, 11139, 11140, 11141, 11142, 11143, 11177, 11111, 11112, 11135, 11190, 11191, 11192, 11100, 11182, 11183, 11185, 11186, 11134, 11122, 11124, 11125. 11126, 11127, 11128, 11129, 11130, 11131, 11132, 11155, 11156, 11157, 11159, 11160, 11161, 11107, 11108, 11176, 11172, 11173, 11174, 11175, 11109. 11151, 11152, 11153, 11154, 11101, 11181, 11184, 11188, 11189, 11178, 11179, 11180, 11162, 11163

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1268-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1268-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-28

Product code EAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)