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Artis Zee Components (2016-03-07)
- Starting date:
- March 7, 2016
- Posting date:
- March 17, 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-57576
Affected Products
A. ARTIS ZEEGO MULTI-AXIS
B. ARTIS ZEE MULTI-PURPOSE
C. ARTIS ZEE FLOOR
D. ARTIS ZEE CEILING
E. ARTIS ZEE BIPLANE
Reason
In the framework of the regular post market surveillance the following problems have been identified: A. In Artis zeego systems, angulations in the vicinity of the c-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. B. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator.
Affected products
A. ARTIS ZEEGO MULTI-AXIS
Lot or serial number
160109
160354
160810
160846
160936
161003
161020
Model or catalog number
10280959
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
B. ARTIS ZEE MULTI-PURPOSE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10094139
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
C. ARTIS ZEE FLOOR
Lot or serial number
136972
137078
137167
137344
137423
137457
137561
Model or catalog number
10094135
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
D. ARTIS ZEE CEILING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
10094137
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY
E. ARTIS ZEE BIPLANE
Lot or serial number
154569
154679
154691
154693
Model or catalog number
10094141
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY