AXIOM Artis DBA, DTA, BDC magnetic navigation and Artis zeego multi-axis, zee multi-purpose, zee floor, zee ceiling, zee biplane (2019-06-11)
- Starting date:
- June 11, 2019
- Posting date:
- June 28, 2019
- 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-70323
Last updated: 2019-06-28
Affected Products
- AXIOM Artis DBA
- AXIOM Artis DTA
- AXIOM Artis BDC magnetic navigation
- Artis zeego multi-axis
- Artis zee multi-purpose
- Artis zee floor
- Artis zee ceiling
- Artis zee biplane
Reason
Siemens is notifying customers of a potential hardware error on Artis zee and AXIOM Artis Systems with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Affected products
A. AXIOM Artis DBA
Lot or serial number
Not applicable.
Model or catalog number
7555357
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
B. AXIOM Artis DTA
Lot or serial number
Not applicable.
Model or catalog number
7008605
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
C. AXIOM Artis BDC magnetic navigation
Lot or serial number
Not applicable.
Model or catalog number
59 17 054
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
D. Artis zeego multi-axis
Lot or serial number
Not applicable.
Model or catalog number
10280959
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
E. Artis zee multi-purpose
Lot or serial number
Not applicable.
Model or catalog number
10094139
7555365
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
F. Artis zee floor
Lot or serial number
Not applicable.
Model or catalog number
10094135
7412807
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
G. Artis zee ceiling
Lot or serial number
Not applicable.
Model or catalog number
10094137
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY
H. Artis zee biplane
Lot or serial number
Not applicable.
Model or catalog number
10094141
7728392
Companies
- Manufacturer
-
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY