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Health product recall

Artis zeego multi-axis, Artis Zee Multi-Purpose and Artis Q (2016-07-06)

Starting date:
July 6, 2016
Posting date:
July 22, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-59484

Affected products

  1. ARTIS ZEEGO MULTI-AXIS
  2. Artis Zee Multi-Purpose
  3. ARTIS Q

    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.

    Affected products

    A. ARTIS ZEEGO MULTI-AXIS

     

    Lot or serial number

    161020

    Model or catalog number

    10280959

    Companies
    Manufacturer

    Siemens AG

    Wittelsbacherplatz 2

    Muenchen

    80333

    GERMANY



    B. Artis Zee Multi-Purpose

     

    Lot or serial number

    158222

    158224

     

    Model or catalog number

    10094139

    Companies
    Manufacturer

    Siemens AG

    Wittelsbacherplatz 2

    Muenchen

    80333

    GERMANY



    C. ARTIS Q

    Lot or serial number

    109199

    Model or catalog number

    10848281

    Companies
    Manufacturer

    Siemens AG

    Wittelsbacherplatz 2

    Muenchen

    80333

    GERMANY