Artis zee biplane, Artis Q and Artis Q.zen (2018-10-24)

Starting date:

October 24, 2018

Posting date:

November 2, 2018

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-68190

• 
  Reason
• 
  Affected products

Affected products

1. Artis zee biplane
2. Artis Q
3. Artis Q.zen

Reason

In affected Artis Systems, vibrations of the C-arm of plane B may result in reduced image quality. As a root cause the ceiling bearing and screw connection to the c-arm in the ceiling support, known as the rotation unit, has been identified. If the connection which consists of twelve screws is not mounted exactly as specified, this may lead to an increase in vibrations which may have a negative impact on image quality. The effects on image quality are not obvious immediately, but will increase over time. This issue can be attributed to one dedicated production batch of ceiling bearings.

Affected products