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Contamination of ARTIS Systems (2016-07-27)
- Starting date:
- July 27, 2016
- Posting date:
- August 19, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-59862
Affected products
- AXIOM ARTIS DBA
- AXIOM ARTIS DTA
- AXIOM ARTIS DBC MAGNETIC NAVIGATION
- ARTIS ZEE FLOOR MN
- PROXIMAL HUMERAL PLATE EXTRA LONG
- ARTIS ZEE MULTI-PURPOSE
- ARTIS ZEE FLOOR
- ARTIS ZEE CEILING
- ARTIS ZEE BIPLANE
- 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 TA
- ARTIS Q
- ARTIS Q.ZEN
Reason
Siemens is initiating a field corrective action, as during routine surveillance activities, it was identified that contaminants in the form of biomass can develop in the cooling system of Artis systems, which can result in damage to the pump system. Biomass is developing in the ongoing life time of a system.
Affected products
A. AXIOM ARTIS DBA
B. AXIOM ARTIS DTA
C. AXIOM ARTIS DBC MAGNETIC NAVIGATION
D. ARTIS ZEE FLOOR MN
E. PROXIMAL HUMERAL PLATE EXTRA LONG
F. ARTIS ZEE MULTI-PURPOSE
G. ARTIS ZEE FLOOR
H. ARTIS ZEE CEILING
I. ARTIS ZEE BIPLANE
J. AXIOM ARTIS FC
K. AXIOM ARTIS DFC MAGNETIC NAVIGATION
L. AXIOM ARTIS DFC
M. AXIOM ARTIS FA ALPHA
N. AXIOM ARTIS MP DIAGNOSTIC
O. AXIOM ARTIS BC
P. AXIOM ARTIS BA
Q. AXIOM ARTIS TA
R. ARTIS Q
S. ARTIS Q.ZEN
Lot or serial number
A. 53081
53088
53097
53101
B. More than 10 numbers, contact manufacturer.
C. 49003
D. 140409
E. N/A
F. More than 10 numbers, contact manufacturer.
G. More than 10 numbers, contact manufacturer..
H. More than 10 numbers, contact manufacturer.
I. More than 10 numbers, contact manufacturer.
J. 10376
K.40033
L. 35051
35177
35216
35219
35298
35391
35417
35531
35749
M. N/A
N. N/A
O. 14026
14041
14080
P. 28022
28048
28069
Q. 32070
R. N/A
S. N/A
Model or catalog number
A. 7555357
B. 7008605
C. 5917054
D. 10094142
E. 10280959
F. 10094139
7555365
G. 10094135
H. 10094137
I. 10094141
7728392
J. 59 04 433
K. 7727717
L. 7412807
M. 5904441
N. 5904466
O. 5904649
P. 5904656
Q. 7007755
R. 10848280
10848281
10848282
10848283
S. 10848353
10848355
Companies
- Manufacturer
-
CONTINENTAL SURGICAL
111 ALBERT ST
OTTAWA
K1P 1B1
Ontario
CANADA
A. AXIOM ARTIS DBA
B. AXIOM ARTIS DTA
C. AXIOM ARTIS DBC MAGNETIC NAVIGATION
D. ARTIS ZEE FLOOR MN
E. PROXIMAL HUMERAL PLATE EXTRA LONG
F. ARTIS ZEE MULTI-PURPOSE
G. ARTIS ZEE FLOOR
H. ARTIS ZEE CEILING
I. ARTIS ZEE BIPLANE
J. AXIOM ARTIS FC
K. AXIOM ARTIS DFC MAGNETIC NAVIGATION
L. AXIOM ARTIS DFC
M. AXIOM ARTIS FA ALPHA
N. AXIOM ARTIS MP DIAGNOSTIC
O. AXIOM ARTIS BC
P. AXIOM ARTIS BA
Q. AXIOM ARTIS TA
R. ARTIS Q
S. ARTIS Q.ZEN
Lot or serial number
A. 53081
53088
53097
53101
B. > 10 numbers, contact mfg.
C. 49003
D. 140409
E. N/A
F. More than 10 numbers, contact manufacturer.
G. More than 10 numbers, contact manufacturer..
H. More than 10 numbers, contact manufacturer.
I. More than 10 numbers, contact manufacturer.
J. 10376
K.40033
L. 35051
35177
35216
35219
35298
35391
35417
35531
35749
M. N/A
N. N/A
O. 14026
14041
14080
P. 28022
28048
28069
Q. 32070
R. N/A
S. N/A
Model or catalog number
A. 7555357
B. 7008605
C. 5917054
D. 10094142
E. 10280959
F. 10094139
7555365
G. 10094135
H. 10094137
I. 10094141
7728392
J. 59 04 433
K. 7727717
L. 7412807
M. 5904441
N. 5904466
O. 5904649
P. 5904656
Q. 7007755
R. 10848280
10848281
10848282
10848283
S. 10848353
10848355
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY