Events

Recall of AXIOM ARTIS FA ALPHA

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
    117057
  • Event Risk Class
    III
  • Event Initiated Date
    2015-09-14
  • 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
    It was identified that there is potential that a possible position sensor fault in the swivel base axis is not being detected by the system software. following the enabling of movement by the operator the c-arm system can unexpectedly move faster than normal. please note that the system will not move without movement being initiated by the operator however the speed at which it can move would be faster than normal.

Device

AXIOM ARTIS FA ALPHA
  • Model / Serial
    Model Catalog: 5904441 (Lot serial: ); Model Catalog: 5904656 (Lot serial: ); Model Catalog: 5904466 (Lot serial: ); Model Catalog: 7555357 (Lot serial: (FOR ALL DEVICES)); Model Catalog: 7555357 (Lot serial: VERSION VB23N OR VB35E); Model Catalog: 7555357 (Lot serial: SERIAL #S RUNNING SOFTWARE); Model Catalog: 5904649 (Lot serial: ); Model Catalog: 7412807 (Lot serial: ); Model Catalog: 7555365 (Lot serial: ); Model Catalog: 59 17 054 (Lot serial: ); Model Catalog: 59 04 433 (Lot serial: ); Model Catalog: 7728392 (Lot serial: ); Model Catalog: 7727717 (Lot serial: ); Model Catalog: 7555357 (Lot serial: THE AFFECTED SYSTEMS COVER ALL)
  • Product Description
    AXIOM ARTIS FA ALPHA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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