Events

Recall of 2200 INTRAORAL X-RAY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM HEALTH CANADA 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
    57886
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-18
  • 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
    A potential problem which could result in an early failure of the scissor arm to bracket connection. the failure can be identified by observing the physical condition of the scissor arm bracket. the plastic covers around the bracket typically show signs of fatigue before the bracket actually breaks. this can be an early indicator of a potential problem.

Device

2200 INTRAORAL X-RAY SYSTEM
  • Model / Serial
    Model Catalog: 5153606 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 5153598 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 5153614 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 5153648 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 5153630 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 5153622 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    KODAK 2200 INTRAORAL X-RAY SYSTEM
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

CARESTREAM HEALTH CANADA COMPANY
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    HC