Events

Recall of Device Recall Dental chair headrest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dental Equipment LLC.

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
    55153
  • Event Risk Class
    Class 2
  • Event Number
    Z-2241-2010
  • Event Initiated Date
    2010-03-23
  • Event Date Posted
    2010-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90151
  • 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
    Dental chair headrest - Product Code NRU
  • Reason
    The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet.
  • Action
    DCI Equipment sent an "Urgent Field Safety Alert" letter dated March 15, 2010 to consignees advising them of the potential problem. The letter instructed that patients with implantable pacemakers or defibrillators should avoid dental chairs with the magnetic headrest. A warning label was sent with the letter for insertion into the product Use and Care manual for operator warning. Consignees were asked to complete a Field Safety Alert Acknowledgement/Return Form and fax to the firm. Consignees were requested to notify customers.Consignees may contact the firm at 503 537-3602.

Device

Device Recall Dental chair headrest
  • Model / Serial
    The individual headrests do not have serial numbers. The headrest has a part number of "40R501". The part number is followed by a dash and a 2 or 3 digit number that indicates the color of the vinyl covering.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution in the USA and Canada.
  • Product Description
    The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): || The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: || Marus MaxStar-Agency Model # DC1490; || Marus MaxStar-Agency Model # DC1690; || Marus NuStar-Agency Model # DC1700; || Marus NuStar-Agency Model # DC1702; || Marus ProStar-Agency Model # DC1540; || Marus ProStar-Agency Model # DC1535; || DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and || DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.
  • Manufacturer
    Dental Equipment LLC

Manufacturer

Dental Equipment LLC
  • Manufacturer Address
    Dental Equipment LLC, 705 S Springbrook Rd Bldg B200, Newberg OR 97132-7057
  • Source
    USFDA