Device product
SOMATOM go.Top (Model #1161640), 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-1918-2019
Product summary
- Event
- Event 83081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30
- Official record key
device-enforcement:Z-1918-2019
Official wording
Reason: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
Code information: Serial Number: 119103 119090 119098 119086 119081 119115 119125 119145 119148 119119 119132 119123 119133 119084 119085 119088 119087 119141 119083 119143 119153 119122 119120 119093 119109 119111 119144 119152 119142 119147
Distribution pattern: US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico.
Derived failure modes
-
Unknown
The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.