Somatom Definition AS - Main Unit and Somatom Definition Edge System - CT System (2019-09-05)
- Starting date:
- September 5, 2019
- Posting date:
- October 11, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-71225
Last updated: 2019-10-11
Affected Products
A. Somatom Definition AS - Main Unit
B. Somatom Definition Edge System - CT System
Reason
Sporadic performance problems with the current software version VA44A_SP6 may result in scanning workflow interruptions. Delay in diagnosis or necessity for patient rescan may occur due to these issues. There are no workarounds available for the identified issues. However, Siemens has developed software update CT VA44A_SP7 that includes workflow improvements and bug fixes (firmware software) for stability issues observed in the installed base.
Affected products
A. Somatom Definition AS - Main Unit
Lot or serial number
- 64238
- 65250
- 66673
Model or catalog number
- 8098027
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY
B. Somatom Definition Edge System - CT System
Lot or serial number
- 83053
Model or catalog number
- 10590000
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY