Artis Devices (2016-12-14)

Starting date:

December 14, 2016

Posting date:

January 6, 2017

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-61708

• Reason
• Affected products

Affected Products

A. Artis Zeego Multi-Axis
B. Artis Zee Multi-Purpose
C. Artis Zee Ceiling
D. Artis Zee Biplane
E. Artis Q
F. Artis Q.Zen

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.

Affected products