Events

Recall of ARTIS Q.ZEN

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
    47716
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-14
  • 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
    1. in artis systems with a100plus or a100g generators an attempt to resume operation following detection of fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator. 2. for biplane systems delivered with software version vd11b since april of this year software problems in conjunction with the graphics card may in rare cases result in the loss of image display in the examination room.

Device

ARTIS Q.ZEN
  • Model / Serial
    Model Catalog: 10848355 (Lot serial: ALL); Model Catalog: 10094141 (Lot serial: ALL); Model Catalog: 10280959 (Lot serial: ALL); Model Catalog: 10094139 (Lot serial: ALL); Model Catalog: 10094137 (Lot serial: ALL); Model Catalog: 10848280 (Lot serial: ALL); Model Catalog: 10848281 (Lot serial: ALL); Model Catalog: 10848282 (Lot serial: ALL); Model Catalog: 10848283 (Lot serial: ALL); Model Catalog: 10848353 (Lot serial: ALL)
  • Product Description
    ARTIS Q.ZEN;ARTIS ZEE BIPLANE;ARTIS ZEEGO MULTI-AXIS;ARTIS ZEE MULTI-PURPOSE;ARTIS ZEE CEILING;ARTIS Q
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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