Events

Recall of AXOIM SENSIS XP SYSTEM - HEMODYNAMIC APPLICATION

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

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
    121451
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-17
  • 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
    In sensis system a computer that is extremely dusty can cause problems when starting the system. in rare cases it can cause the sensis to fail. should the sensis system fail its functions can no longer be used. clinical treatment may need to be terminated restarted or transferred to a functioning system.

Device

AXOIM SENSIS XP SYSTEM - HEMODYNAMIC APPLICATION
  • Model / Serial
    Model Catalog: 6634633 (Lot serial: ALL); Model Catalog: 6623974 (Lot serial: ALL); Model Catalog: 6634641 (Lot serial: ALL)
  • Product Description
    AXIOM SENSIS XP SYSTEM-HEMODYNAMIC APPLICATION;AXIOM SENSIS SYSTEM-ELECTROPHYSIOLOGY APPLICATION;AXIOM SENSIS SYSTEM-HEMODYNAMIC APPLICATION
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC