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
  • 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
  • 1 Event

Manufacturer

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