Events

Recall of Cranex Tome panoramic xray

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

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
    37838
  • Event Risk Class
    Class 2
  • Event Number
    Z-0816-2007
  • Event Initiated Date
    2006-04-28
  • Event Date Posted
    2007-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51835
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    panoramic x-ray - Product Code EDH
  • Reason
    There may be a material defect in the up/down movement axle of the unit. this may cause the upper part of the unit to suddenly come down.
  • Action
    A recall letter, dated 04/28/2006, was sent to affected customers . The letter describes the issue, and requests that no patient operation is permitted until the unit is checked by authorized service technician. If the service technician noted wear of the screw, the assembly was replaced.

Device

Cranex Tome panoramic xray
  • Model / Serial
    Serial numbers X51146, X51147, X51148, X51154, X51155, X51156, X51170, X51171, X61188
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Bermuda, and Colombia.
  • Product Description
    Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.
  • Manufacturer
    Instrumentarium Dental, Inc.

Manufacturer

Instrumentarium Dental, Inc.
  • Manufacturer Address
    Instrumentarium Dental, Inc., 300 West Edgerton Avenue, Milwaukee WI 53207
  • Source
    USFDA