Axiom Artis - dFA, dBA, dTA, FC, dFC, FA Alpha, MP Diagnostic, BC, BA, TA, dTC, dBC, and dBC, dFC Magnetic Navigation; Artis - Zee Floor MN, Q and Q.Zen, Artis - Zee Biplane MN, Zeego Multi-Axis, Zee Floor, Zee Floor MN, Zee Ceiling, Zee Biplane (201...
- Starting date:
- December 11, 2017
- Posting date:
- January 12, 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-65538
Affected Products
A. AXIOM ARTIS DFA
B. AXIOM ARTIS DBA
C. AXIOM ARTIS DTA
D. AXIOM ARTIS DBC MAGNETIC NAVIGATION
E. ARTIS ZEE FLOOR MN
F. ARTAIS ZEE BIPLANE MN
G. ARTIS ZEEGO MULTI-AXIS
H. ARTIS ZEE FLOOR
I. ARTIS ZEE CEILING
J. ARTIS ZEE BIPLANE
K. AXIOM ARTIS FC
L. AXIOM ARTIS DFC MAGNETIC NAVIGATION
M. AXIOM ARTIS DFC
N. AXIOM ARTIS FA ALPHA
O. AXIOM ARTIS MP DIAGNOSTIC
P. AXIOM ARTIS BC
Q. AXIOM ARTIS BA
R. AXIOM ARTIS TA
S. AXIOM ARTIS DTC
T. AXIOM ARTIS DBC
U. ARTIS Q
V. ARTIS Q.ZEN
Reason
For Artis Systems in conjunction with the Artis Table: The Artis Table Top Carriage is mounted on top of the table base and fixed with a bolt. A snap ring is used to secure the bolt. In rare cases, it was identified that the snap ring is not properly fixed. In case of a missing or wrongly installed snap ring, the bolt could slide out of its base, and the Table Top Carriage could slide to the floor.
Affected products
A. AXIOM ARTIS DFA
Lot or serial number
Not applicable
Model or catalog number
7555373
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
B. AXIOM ARTIS DBA
Lot or serial number
Not applicable
Model or catalog number
7555357
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
C. AXIOM ARTIS DTA
Lot or serial number
Not applicable
Model or catalog number
7008605
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
D. AXIOM ARTIS DBC MAGNETIC NAVIGATION
Lot or serial number
Not applicable
Model or catalog number
5917054
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
E. ARTIS ZEE FLOOR MN
Lot or serial number
Not applicable
Model or catalog number
10094142
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
F. ARTAIS ZEE BIPLANE MN
Lot or serial number
Not applicable
Model or catalog number
10094143
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
G. ARTIS ZEEGO MULTI-AXIS
Lot or serial number
Not applicable
Model or catalog number
10280959
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
H. ARTIS ZEE FLOOR
Lot or serial number
Not applicable
Model or catalog number
10094135
7412807
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
I. ARTIS ZEE CEILING
Lot or serial number
Not applicable
Model or catalog number
10094137
7413078
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
J. ARTIS ZEE BIPLANE
Lot or serial number
Not applicable
Model or catalog number
10094141
7728392
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
K. AXIOM ARTIS FC
Lot or serial number
Not applicable
Model or catalog number
5904433
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
L. AXIOM ARTIS DFC MAGNETIC NAVIGATION
Lot or serial number
Not applicable
Model or catalog number
7727717
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
M. AXIOM ARTIS DFC
Lot or serial number
Not applicable
Model or catalog number
10094135
7412807
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
N. AXIOM ARTIS FA ALPHA
Lot or serial number
Not applicable
Model or catalog number
5904441
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
O. AXIOM ARTIS MP DIAGNOSTIC
Lot or serial number
Not applicable
Model or catalog number
5904466
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
P. AXIOM ARTIS BC
Lot or serial number
Not applicable
Model or catalog number
5904649
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
Q. AXIOM ARTIS BA
Lot or serial number
Not applicable
Model or catalog number
5904656
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
R. AXIOM ARTIS TA
Lot or serial number
Not applicable
Model or catalog number
7007755
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
S. AXIOM ARTIS DTC
Lot or serial number
Not applicable
Model or catalog number
10094137
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
T. AXIOM ARTIS DBC
Lot or serial number
Not applicable
Model or catalog number
10094141
7728392
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
U. ARTIS Q
Lot or serial number
Not applicable
Model or catalog number
10848280
10848281
10848282
10848283
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY
V. ARTIS Q.ZEN
Lot or serial number
Not applicable
Model or catalog number
10848353
10848354
10848355
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY