Artis Imaging Systems (2015-05-29)

Starting date:

May 29, 2015

Posting date:

June 12, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53769

• Reason
• Affected products

Recalled Products

A. Artis Zee Multi-Purpose
B. Artis Zee Floor
C. Artis Zee Biplane
D. Artis Q
E. Artis Q.zen

Reason

It was identified that there is potential that a possible position sensor fault in the swivel base axis is not being detected by the system software.  Following the enabling of movement by the operator, the C-arm system can unexpectedly move faster than normal.  Please note that the system will not move without movement being initiated by the operator, however, the speed at which it can move would be faster than normal.

Affected products