Recall of CH-200 CEILING TUBE SUPPORT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CHRISTIE INNOMED 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
    56385
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-13
  • Event Country
  • 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
    The x-ray tube assembly in this device is mounted on a tube mounting flange which is part of the tube holding shaft. it was found that extremely infrequently cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. if these cracks occur and then increase in size the tube mounting flange may separate from the tube holding shaft.

Device

  • Model / Serial
    Model Catalog: CH-200 (Lot serial: 016M46108)
  • Product Description
    CH-200 CEILING TUBE SUPPORT
  • Manufacturer

Manufacturer