Events

Recall of ARTIS ZEEGO MULTI-AXIS

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
    17711
  • Event Risk Class
    III
  • Event Initiated Date
    2014-08-05
  • 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
    Product monitoring has revealed a possible defect in the x-ray tube cooling device in the affected systems. the input fuse of the cooling device can be damaged when the system is switched on. the cooling device is therefore no longer available for cooling the tube at the start of a procedure. this information is displayed to the user but a procedure can be started nonetheless. however the x-ray tube can fail after a certain time and radiation will no longer be available.

Device

ARTIS ZEEGO MULTI-AXIS
  • Model / Serial
    Model Catalog: 10280959 (Lot serial: 160810); Model Catalog: 10094135 (Lot serial: 136972); Model Catalog: 10094137 (Lot serial: 147097); Model Catalog: 10094137 (Lot serial: 147754); Model Catalog: 10094139 (Lot serial: 157633); Model Catalog: 10094135 (Lot serial: 136556); Model Catalog: 10094139 (Lot serial: 158068); Model Catalog: 10094139 (Lot serial: 158067); Model Catalog: 10094139 (Lot serial: 158065); Model Catalog: 10094139 (Lot serial: 157695); Model Catalog: 10094139 (Lot serial: 157686); Model Catalog: 10094139 (Lot serial: 157680)
  • Product Description
    ARTIS ZEEGO MULTI-AXIS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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