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Health product recall

SOMATOM Products

Starting date:
December 21, 2012
Posting date:
January 7, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-16669

Recalled Products

A. SOMATOM Definition – Main Unit

B. SOMATOM Definition – AS – Main Unit

C. SOMATOM Definition Flash Sys – Main Unit

Reason

There is a highly sporadic malfunction that concerns the 3D reconstruction functionality of the SOMATOM Systems. This problem may occur during the process of a 3D reconstruction job planning and editing within a specific funtionality, while another functionality ("preview image") is activated. The problem presents itself as an error message window and the system needs to be rebooted.

Affected products

A. SOMATOM Definition – Main Unit

Lot or serial number

Any Serial Number running Software Version VA20, VA27, VA34 or VA40

Model or catalog number

77 40 769

Companies
Manufacturer
Siemens Ag
Wittelsbacherplatz 2
Muenchen
80333
GERMANY

B. SOMATOM Definition – AS – Main Unit

Lot or serial number

Any Serial Number running Software Version VA20, VA27, VA34 or VA40

Model or catalog number

8098027

Companies
Manufacturer
Siemens Ag
Wittelsbacherplatz 2
Muenchen
80333
GERMANY

C. SOMATOM Definition Flash Sys – Main Unit

Lot or serial number

Any Serial Number running Software Version VA20, VA27, VA34 or VA40

Model or catalog number

10430603

Companies
Manufacturer
Siemens Ag
Wittelsbacherplatz 2
Muenchen
80333
GERMANY