Events

Recall of ARTIS ZEE BIPLANE

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
    35442
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-12
  • 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
    If a network problem arises that puts the system into the operating mode "bypass fluoro" while the function "block radiation" is activated this function cannot be deactivated again by once more pressing the "block radiation" key on the tsc (touch screen control). even in positions which are different from the patient transfer position and the park position the system then displays the message "xray manually disabled.".

Device

ARTIS ZEE BIPLANE
  • Model / Serial
    Model Catalog: 10094141 (Lot serial: 153146); Model Catalog: 10094141 (Lot serial: 153223); Model Catalog: 10094141 (Lot serial: 153275); Model Catalog: 10094141 (Lot serial: 153854); Model Catalog: 10094141 (Lot serial: 153372)
  • Product Description
    ARTIS ZEE BIPLANE SYSTEMS RUNNING ARTIS VC1X SW
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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