FDA Recall
Terminated
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Recall: Z-0907-2014
·
Initiated November 15, 2013
Recall
- Recall Number
- Z-0907-2014
- Event Number
- 67138
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 15, 2013
- Posted
- February 3, 2014
- Terminated
- March 10, 2015
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355
Description
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Reason
During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.
Action
A recall notification letter, dated November 15, 2013, was sent to Users.
Distribution
Nationwide Distribution.
Quantity
147