FDA Recall
Terminated
Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Recall: Z-0320-2009
·
Initiated September 3, 2008
Recall
- Recall Number
- Z-0320-2009
- Event Number
- 50077
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- September 3, 2008
- Posted
- January 5, 2009
- Terminated
- September 23, 2009
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355-1406
Description
Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Reason
software error - does not allow protocol to properly synchronize with ECG triggers
Action
The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500.
Distribution
Nationwide
Quantity
168 units