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AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEMS (2015-09-14)
- Starting date:
- September 14, 2015
- Posting date:
- October 5, 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-55224
Affected Products
- AXIOM ARTIS DBA
- AXIOM ARTIS DMP
- AXIOM ARTIS DBC MAGNETIC NAVIGATION
- AXIOM ARTIS FC
- AXIOM ARTIS DFC MAGNETIC NAVIGATION
- AXIOM ARTIS DFC
- AXIOM ARTIS FA ALPHA
- AXIOM ARTIS MP DIAGNOSTIC
- AXIOM ARTIS BC
- AXIOM ARTIS BA
- AXIOM ARTIS DBC
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
A. AXIOM ARTIS DBA
Lot or serial number
Not applicable
Model or catalog number
7555357
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
B. AXIOM ARTIS DMP
Lot or serial number
Not applicable
Model or catalog number
7555365
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
C. AXIOM ARTIS DBC MAGNETIC NAVIGATION
Lot or serial number
Not applicable
Model or catalog number
59 17 054
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
D. AXIOM ARTIS FC
Lot or serial number
Not applicable
Model or catalog number
59 04 433
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
E. AXIOM ARTIS DFC MAGNETIC NAVIGATION
Lot or serial number
Not applicable
Model or catalog number
7727717
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
F. AXIOM ARTIS DFC
Lot or serial number
Not applicable
Model or catalog number
7412807
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
G. AXIOM ARTIS FA ALPHA
Lot or serial number
Not applicable
Model or catalog number
5904441
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
H. AXIOM ARTIS MP DIAGNOSTIC
Lot or serial number
Not applicable
Model or catalog number
5904466
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
I. AXIOM ARTIS BC
Lot or serial number
Not applicable
Model or catalog number
5904649
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
J. AXIOM ARTIS BA
Lot or serial number
Not applicable
Model or catalog number
5904656
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
K. AXIOM ARTIS DBC
Lot or serial number
Not applicable
Model or catalog number
7728392
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY