Events

Recall of AXIOM ARTIS DFC

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
    64866
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-09
  • 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
    For the below artis systems: -artis q systems with sw version vd11 and gigalix x-ray tubes -artis zee with sw versions vc21c vd11 and megalix cat+ x-ray tubes -axiom artis systems with sw version vb35e and megalix x-ray tubes the semi-automatic focus switch may in cases of a special type of defect in foci "small" and "micro" (if present) does not work as intended when pressing the footswitch multiple times. this special type of focus defect that causes the failure of the semi-automated focus switch becomes more likely as the service life of the x-ray tube increases.

Device

AXIOM ARTIS DFC
  • Model / Serial
    Model Catalog: 7412807 (Lot serial: ALL); Model Catalog: 7728392 (Lot serial: ALL); Model Catalog: 7555365 (Lot serial: ALL); Model Catalog: 10094142 (Lot serial: ALL); Model Catalog: 7008605 (Lot serial: ALL); Model Catalog: 10094135 (Lot serial: ALL); Model Catalog: 10094139 (Lot serial: ALL); Model Catalog: 10094137 (Lot serial: ALL); Model Catalog: 7555357 (Lot serial: ALL); Model Catalog: 10280959 (Lot serial: ALL); Model Catalog: 10848353 (Lot serial: ALL); Model Catalog: 10094141 (Lot serial: ALL); Model Catalog: 10848280 (Lot serial: ALL); Model Catalog: 10848281 (Lot serial: ALL); Model Catalog: 10848282 (Lot serial: ALL); Model Catalog: 10848283 (Lot serial: ALL); Model Catalog: 10848355 (Lot serial: ALL)
  • Product Description
    AXIOM ARTIS DFC;AXIOM ARTIS DBC;AXIOM ARTIS DMP;AXIOM ARTIS ZEE FLOOR MN;AXIOM ARTIS DTA;ARTIS ZEE FLOOR;ARTIS ZEE MULTI-PURPOSE;ARTIS ZEE CEILING;AXIOM ARTIS DBA;ARTIS ZEEGO MULTI-AXIS;ARTIS Q.ZEN;ARTIS ZEE BIPLANE;ARTIS Q
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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