Events

Recall of ORTHORALIX 9200 DDE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HENRY SCHEIN CANADA 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
    48519
  • Event Risk Class
    III
  • Event Initiated Date
    2011-07-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Gendex received customer complaints alleged that images taken with the orthoralis 9200 dde panoramic dental x-ray systems were either distorted fragmented flipped negative reversed or had lines across them. the image distortion could not be used for diagnostic purposes.

Device

ORTHORALIX 9200 DDE
  • Model / Serial
    Model Catalog: P9212DDE (Lot serial: 427380); Model Catalog: 51050161WW (Lot serial: 427381); Model Catalog: 110-0199G2 (Lot serial: 230039); Model Catalog: 110-0199G4 (Lot serial: 230039); Model Catalog: P9212DDE (Lot serial: 427381); Model Catalog: P9200DDEC (Lot serial: 427381); Model Catalog: P9200DDEC (Lot serial: 427380); Model Catalog: 51050181WW (Lot serial: 427380); Model Catalog: 51050161WW (Lot serial: 427380); Model Catalog: 51050181WW (Lot serial: 427381); Model Catalog: 110-0234G3 (Lot serial: 230039); Model Catalog: 110-0234G1 (Lot serial: 230039); Model Catalog: P9212DDE (Lot serial: ); Model Catalog: P9200DDEC (Lot serial: ); Model Catalog: P9200DDE (Lot serial: )
  • Product Description
    ORTHORALIX 9200 DDE
  • Manufacturer
    HENRY SCHEIN CANADA INC.

Manufacturer

HENRY SCHEIN CANADA INC.
  • Manufacturer Address
    NIAGARA-ON-THE-LAKE
  • Manufacturer Parent Company (2017)
    Henry Schein Inc
  • Source
    HC