Events

Recall of AXIOM ARTIS BA

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
    136703
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-06
  • 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
    The field action ax002/15/s was previously performed to protect the artis table against liquid entry at critical locations. however it was further identified that larger amounts of liquid can still enter the table. this may result in electric table movement failure. this corrective action will increase the protection against liquid entry into the artis table.

Device

AXIOM ARTIS BA
  • Model / Serial
    Model Catalog: 5904656 (Lot serial: N/A); Model Catalog: 7007755 (Lot serial: N/A); Model Catalog: 10094141 (Lot serial: N/A); Model Catalog: 7728392 (Lot serial: N/A); Model Catalog: 10094137 (Lot serial: N/A); Model Catalog: 7727717 (Lot serial: N/A); Model Catalog: 10094142 (Lot serial: N/A); Model Catalog: 5904649 (Lot serial: N/A); Model Catalog: 10094135 (Lot serial: N/A); Model Catalog: 7008605 (Lot serial: N/A); Model Catalog: 5904433 (Lot serial: N/A); Model Catalog: 59 17 054 (Lot serial: N/A); Model Catalog: 10848283 (Lot serial: N/A); Model Catalog: 10848282 (Lot serial: N/A); Model Catalog: 10848281 (Lot serial: N/A); Model Catalog: 10848280 (Lot serial: N/A); Model Catalog: 10848355 (Lot serial: N/A); Model Catalog: 10848354 (Lot serial: N/A); Model Catalog: 10848353 (Lot serial: N/A); Model Catalog: 5904441 (Lot serial: N/A); Model Catalog: 10280959 (Lot serial: N/A); Model Catalog: 7555357 (Lot serial: N/A); Model Catalog: 7412807 (Lot serial: N/A)
  • Product Description
    AXIOM ARTIS BA;AXIOM ARTIS TA;ARTIS ZEE BIPLANE;ARTIS ZEE CEILING;AXIOM ARTIS DFC MAGNETIC NAVIGATION;ARTIS ZEE FLOOR MN;AXIOM ARTIS BC;ARTIS ZEE FLOOR;AXIOM ARTIS DTA;AXIOM ARTIS FC;AXIOM ARTIS DBC MAGNETIC NAVIGATION;ARTIS Q;ARTIS Q.ZEN;AXIOM ARTIS FA A
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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