Events

Recall of ESOPHAGUS SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CSP MEDICAL.

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
    19239
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-16
  • 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
    If the applicator fixation is not securely fixated to the bougie tube or the universal applicator there is a risk of a misplacement of the source so that not the target area but healthy tissue would be irridiated. therefore according to a safety advice in the instructions for use the user has to verify that the applicator fixation is safely fixated to the bougie tube. according to the current procedure this check is carried out after the bougie tube has been introduced. due to the product failure it will not be possible to correct the tightening of the applicator fixation. as a result the patient would have to leave untreated after having been sedated and undergoing the stressful introduction of the bougie tube.

Device

ESOPHAGUS SET
  • Model / Serial
    Model Catalog: SET0019 (Lot serial: all batches)
  • Product Description
    ESOPHAGUS SET
  • Manufacturer
    CSP MEDICAL

Manufacturer

CSP MEDICAL
  • Manufacturer Address
    LONDON
  • Manufacturer Parent Company (2017)
    CSP Medical
  • Source
    HC