Events

Recall of ARTAIS ZEE BIPLANE MN

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
    19495
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-11
  • 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 artis systems in conjunction with the artis table: the artis table top carriage is mounted on top of the table base and fixed with a bolt. a snap ring is used to secure the bolt. in rare cases it was identified that the snap ring is not properly fixed. in case of a missing or wrongly installed snap ring the bolt could slide out of its base and the table top carriage could slide to the floor.

Device

ARTAIS ZEE BIPLANE MN
  • Model / Serial
    Model Catalog: 10094143 (Lot serial: N/A); Model Catalog: 5904656 (Lot serial: N/A); Model Catalog: 7007755 (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: 10094141 (Lot serial: N/A); Model Catalog: 7728392 (Lot serial: N/A); Model Catalog: 10280959 (Lot serial: N/A); Model Catalog: 10094135 (Lot serial: N/A); Model Catalog: 7412807 (Lot serial: N/A); Model Catalog: 5904466 (Lot serial: N/A); Model Catalog: 7555357 (Lot serial: N/A); Model Catalog: 7555373 (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: 59 17 054 (Lot serial: N/A); Model Catalog: 5904433 (Lot serial: N/A); Model Catalog: 7008605 (Lot serial: N/A); Model Catalog: 5904649 (Lot serial: N/A); Model Catalog: 10094137 (Lot serial: N/A); M
  • Product Description
    ARTAIS ZEE BIPLANE MN;AXIOM ARTIS BA;AXIOM ARTIS TA;ARTIS Q;AXIOM ARTIS DBC;ARTIS ZEEGO MULTI-AXIS;AXIOM ARTIS DFC;AXIOM ARTIS MP DIAGNOSTIC;AXIOM ARTIS DBA;AXIOM ARTIS DFA;ARTIS Q.ZEN;AXIOM ARTIS FA ALPHA;AXIOM ARTIS DBC MAGNETIC NAVIGATION;AXIOM ARTIS F
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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