Events

Recall of Device Recall Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest

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

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
    54719
  • Event Risk Class
    Class 2
  • Event Number
    Z-1325-2010
  • Event Initiated Date
    2010-02-24
  • Event Date Posted
    2010-04-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90464
  • 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
    Chair, dental, with operative unit - Product Code KLC
  • Reason
    Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
  • Action
    Pelton & Crane Issued an "Urgent Field Safety Alert" notification dated February 24, 2010. Consignees were instructed of the affected product and informed of proper actions to take. For further information, contact Pelton & Crane at 1-704-588-2126.

Device

Device Recall Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest
  • Model / Serial
    All Devices with Model Number SP20
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany.
  • Product Description
    Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. || Intended for the properly positioning of patients to perform dental procedures.
  • Manufacturer
    Pelton & Crane Company

Manufacturer

Pelton & Crane Company
  • Manufacturer Address
    Pelton & Crane Company, 11727 Fruehauf Dr, Charlotte NC 28273
  • Manufacturer Parent Company (2017)
    Pelton & Crane Company
  • Source
    USFDA