Device product
SOMATOM go.All (Model #11061630), 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-1917-2019
Product summary
- Event
- Event 83081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-1917-2019
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: 117515 117476 117529 117492 117501 117515 117500 117522 117523 117484 117498 117517 117512 117505 117479 117516 117510 117495 117482 117521 117496 117508 117533 117483
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.