AXIOM Systems (2016-11-09)

Starting date:

November 9, 2016

Posting date:

November 25, 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-61208

• Reason
• Affected products

Affected Products

• A. AXIOM ARTIS DBA
• B. AXIOM ARTIS DTA
• C. AXIOM ARTIS DMP
• D. AXIOM ARTIS ZEE FLOOR MN
• E. ARTIS ZEEGO Multi-Axis
• F. ARTIS ZEE Multi-Purpose
• G. ARTIS ZEE Floor
• H. ARTIS ZEE Ceiling
• I. ARTIS ZEE Biplane
• J. AXIOM ARTIS DFC
• K. AXIOM ARTIS DBC
• L. ARTIS Q
• M. ARTIS Q.ZEN

Reason

For the below ARTIS Systems: 

• ARTIS Q Systems with SW Version VD11 and Gigalix X-Ray Tubes
• ARTIS Zee with SW Versions VC21C, VD11 and Megalix Cat+ X-Ray Tubes
• AXIOM ARTIS Systems with SW Version VB35E and Megalix X-Ray Tubes

The semi-automatic focus switch may, in cases of a special type of defect in foci "small" and "micro" (if present), not work as intended when pressing the footswitch multiple times. This special type of focus defect that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.

Affected products