Device product
SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.
Z-1921-2019
Product summary
- Event
- Event 83112
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69
- Official record key
device-enforcement:Z-1921-2019
Official wording
Reason: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Code information: 118151
Distribution pattern: US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and WI
Derived failure modes
-
Unknown
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.