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Recall Observatory FDA recall evidence

Device 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.

Z-1268-2016

March 08, 2016

Class II

Product summary

Firm
Pelton & Crane / Marus / DCI Equipment / KaVo
Event
Event 73460
Status
Terminated
Classification
Class II
Quantity
156 units
Official record key
device-enforcement:Z-1268-2016

Official wording

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.

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.