Events

Recall of Device Recall Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair

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
    54809
  • Event Risk Class
    Class 3
  • Event Number
    Z-1311-2010
  • Event Initiated Date
    2010-02-09
  • Event Date Posted
    2010-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89221
  • 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
    Spirit 3000 dental chair - Product Code KLC
  • Reason
    The dental chair lacks a valid device history record.
  • Action
    An "URGENT MEDICAL DEVICE RECALL" letter dated February 9, 2010, was delivered in person to the customer. The letter describe the product, problem and action to be taken by the customer. The customer was requested to provide the name and location of the consignee who received the chair so that Pelton & Crane can contact the end user to arrange to replace the affected chair with a new dental chair, and to complete the enclosed Recall Acknowledgement/Return Form and fax to (704) 587-7204. A monthly status report will be submitted to FDA. Please contact Pelton & Crane Customer Care at 1-800-659-6560 or call Mr. Frank Ray directly at 704-587-7227 to let us know where the device is currently stored.

Device

Device Recall Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair
  • Model / Serial
    Catalog number: 3003, Model number: SP30, Chair Serial #14736
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: NC
  • Product Description
    Pelton & Crane Spirit 3000 Dental Chair. || The intended use of this device is for properly positioning 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