Device product
SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems 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. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
Z-2268-2019
Product summary
- Event
- Event 83377
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2268-2019
Official wording
Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Code information: Serial Numbers: 98474 92280 92261 65370 66032 66649 65299 92298 64516 92335 92300 66062 64218 92313 92296 92254 64051 92342 92277 92307 92336 92315 92288 98473 65145 65493 92323 92321 92243
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Device software or design
software issues impacting systems utilizing syngo.CT software version VB10A which may result in