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Class 2 Device Recall Helios |
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Date Initiated by Firm |
March 08, 2016 |
Create Date |
March 28, 2016 |
Recall Status1 |
Terminated 3 on June 06, 2016 |
Recall Number |
Z-1268-2016 |
Recall Event ID |
73460 |
Product Classification |
Light, operating, dental - Product Code EAZ
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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.
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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 |
Recalling Firm/ Manufacturer |
Pelton & Crane / Marus / DCI Equipment / KaVo 11727 Fruehauf Dr Charlotte NC 28273-6507
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For Additional Information Contact |
Frank Ray 704-587-7227
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Manufacturer 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.
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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