Events

Recall of Device Recall Helios

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pelton & Crane / Marus / DCI Equipment / KaVo.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73460
  • Event Risk Class
    Class 2
  • Event Number
    Z-1268-2016
  • Event Initiated Date
    2016-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144228
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Light, operating, dental - Product Code EAZ
  • 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.
  • 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.

Device

Device Recall Helios
  • Model / Serial
    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
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Pelton & Crane / Marus / DCI Equipment / KaVo

Manufacturer

Pelton & Crane / Marus / DCI Equipment / KaVo
  • Manufacturer Address
    Pelton & Crane / Marus / DCI Equipment / KaVo, 11727 Fruehauf Dr, Charlotte NC 28273-6507
  • Source
    USFDA