Events

Recall of AXIOM ARISTOS FX

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
    151051
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-13
  • 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
    Siemens is informing customers a possible hazard to patients or operators when moving the ceiling suspension of all axiom aristos fx systems (pn 7414803) with serial numbers up to and including 1168. in the event the 3 wheeled cable cart moves behind the point of the fixed cable holder the corrugated hose may get stuck behind the hose from the fixed cable holder. and in case the cable cart and the corrugated hose cannot move freely the cable cart may get pushed out of the ceiling suspension if it is pulled into the direction of the tube stand. if this occurs there is a potential for the cable holder to drop down. only the cable holders with 3 wheels are affected. cable holders with 4 wheels are not affected by this malfunction.

Device

AXIOM ARISTOS FX
  • Model / Serial
    Model Catalog: 7414803 (Lot serial: 1069 1070 1072 1111 1119); Model Catalog: 7414803 (Lot serial: SERIAL # 1046 1065 1067); Model Catalog: 7414803 (Lot serial: 1128 1162)
  • Product Description
    AXIOM ARISTOS FX
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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