Artis Zee & Artis Q Systems (2020-08-13)
- Starting date:
- August 13, 2020
- Posting date:
- September 4, 2020
- 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-73855
Last updated:
2020-09-04
Affected Products
- Artis Zee Multi-purpose
- Artis Zee Ceiling
- Artis Zee Biplane
- Artis Q
- Artis Q Zen
Reason
Siemens became aware of a potential issue with Artis Zee or Artis Q systems. Following the manual installation of the software VD11C patch previously distributed, a potential loss of individual room configuration data settings, which are responsible for collision supervision of X-ray systems, may occur. Therefore, a potential danger of collision with fix mounted room equipment, walls or floor may occur. The issue was identified during monitoring activities and has not been observed in the field.
Affected products
A. Artis Zee Multi-purpose
Lot or serial number
- 158097
Model or catalog number
- 10094139
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY
B. Artis Zee Ceiling
Lot or serial number
- 148244
Model or catalog number
- 10094137
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY
C. Artis Zee Biplane
Lot or serial number
- 123214
- 154569
- 154679
Model or catalog number
- 10094141
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY
D. Artis Q
Lot or serial number
- 117102
Model or catalog number
- 10848283
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY
E. Artis Q Zen
Lot or serial number
- 123214
Model or catalog number
- 10848355
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY