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
Affected products
- Artis zee biplane
- Artis Q
- 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
A. Artis zee biplane
Lot or serial number
All
Model or catalog number
10094141
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
B. Artis Q
Lot or serial number
All
Model or catalog number
10848282
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
C. Artis Q.zen
Lot or serial number
All
Model or catalog number
10848355
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY