CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report

Helios HL3T and HLT Track Mounted Dental Lights recalled

Pelton & Crane / Marus / DCI Equipment / KaVo is recalling Helios HL3T and HLT Track Mounted Dental Lights, distributed nationwide in the US. The recall was initiated on 8 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/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

Quantity recalled156 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1268-2016
FDA event ID: 73460
Recalling firm: Pelton & Crane / Marus / DCI Equipment / KaVo, Charlotte, NC
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2016
FDA classified: 28 Mar 2016
Reported: 6 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Dental Devices

Timeline

8 Mar 2016	Recall initiated by company
28 Mar 2016	Classified by FDA	+20 days
6 Apr 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arkansas Arizona California Colorado Connecticut Florida Iowa Idaho Illinois Indiana Massachusetts Michigan Minnesota North Carolina New Jersey New York Ohio Oregon Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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