Events

Recall of Device Recall Pelton & Crane Spirit 1800

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
    58105
  • Event Risk Class
    Class 2
  • Event Number
    Z-1851-2011
  • Event Initiated Date
    2011-03-04
  • Event Date Posted
    2011-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98356
  • 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 - Product Code NRU
  • Reason
    The link arm assembly that connects some rear mounted options to the spirit 3000 or spirit 1800 dental chairs may potentially break and fall off the dental chair.
  • Action
    Pelton & Crane sent an "Urgent Medical Device Recall" letter dated 3/04/2011. They were instructed to: Locate the affected devices this recall is in regards to. Schedule service with the end user for Pelton & Crane representative to replace the affected components this recall is in regards to. International accounts were instructed to order link arm assemblies from Pelton & Crane and replace the affected components. All consignees were to complete the Recall Acknowledgement/Return Form and return the form to Pelton & Crane.

Device

Device Recall Pelton & Crane Spirit 1800
  • Model / Serial
    Agency model #SP18, Catalog model #1802 and 1803, all units.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution to USA, Canada, and the Netherlands.
  • Product Description
    Pelton & Crane Spirit 1800 dental chair (Model #SP18)
  • 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