Events

Recall of ARTIS Q

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
    86286
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-07
  • 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
    As part of regular post market surveillance activities siemens discovered an error in the 19" live display such that image reproduction may fail in the examination room. the loss of image can only occur immediately after system startup. this failure does not occur during normal operation or when the live image is displayed. only systems which use a live display (reference dshc1914-dc with part number 10656055) in the examination room are affected. live displays with other part numbers are not affected by this issue.

Device

ARTIS Q
  • Model / Serial
    Model Catalog: 10848281 (Lot serial: 109199); Model Catalog: 10094139 (Lot serial: 158224); Model Catalog: 10094139 (Lot serial: 158222); Model Catalog: 10280959 (Lot serial: 161020)
  • Product Description
    ARTIS Q;ARTIS ZEE MULTIPURPOSE;ARTIS ZEEGO MULTI-AXIS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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