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Siemens Artis Systems and Parts (2016-02-22)
- Starting date:
- February 22, 2016
- Posting date:
- March 4, 2016
- 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-57394
Affected Products
- A. AXIOM ARTIS DBA
- B. AXIOM ARTIS DTA
- C. AXIOM ARTIS DBC MAGNETIC NAVIGATION
- D. ARTIS ZEEGO MULTI-AXIS
- E. ARTIS ZEE MULTI-PURPOSE
- F. ARTIS ZEE FLOOR
- G. ARTIS ZEE CEILING
- H. ARTIS ZEE BIPLANE
- I. AXIOM ARTIS DFC MAGNETIC NAVIGATION
- J. ELECTROSURGICAL HF MONOPOLAR CONNECTING CABLE
- K. ARTIS Q
- L. ARTIS Q.ZEN
Reason
Siemens is initiating a field corrective action for failures found when operating the cooling device of the detector which could lead to a leakage of the cooling circuit. This was issue was found during routine quality assurance checks.
Affected products
A. AXIOM ARTIS DBA
Lot or serial number
ALL
Model or catalog number
- 7555357
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
B. AXIOM ARTIS DTA
Lot or serial number
ALL
Model or catalog number
- 7008605
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
C. AXIOM ARTIS DBC MAGNETIC NAVIGATION
Lot or serial number
ALL
Model or catalog number
- 59 17 054
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
D. ARTIS ZEEGO MULTI-AXIS
Lot or serial number
ALL
Model or catalog number
- 10280959
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
E. ARTIS ZEE MULTI-PURPOSE
Lot or serial number
ALL
Model or catalog number
- 10094139
- 7555365
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
F. ARTIS ZEE FLOOR
Lot or serial number
ALL
Model or catalog number
- 10094135
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
G. ARTIS ZEE CEILING
Lot or serial number
ALL
Model or catalog number
- 10094137
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
H. ARTIS ZEE BIPLANE
Lot or serial number
ALL
Model or catalog number
- 10094141
- 7728392
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
I. AXIOM ARTIS DFC MAGNETIC NAVIGATION
Lot or serial number
ALL
Model or catalog number
- 7727717
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
J. ELECTROSURGICAL HF MONOPOLAR CONNECTING CABLE
Lot or serial number
ALL
Model or catalog number
- 7412807
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
K. ARTIS Q
Lot or serial number
ALL
Model or catalog number
- 10848280
- 10848281
- 10848282
- 10848283
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
L. ARTIS Q.ZEN
Lot or serial number
ALL
Model or catalog number
- 10848353
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY