Z-2268-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- July 3, 2019
- Termination Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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).
Reason for Recall
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Distribution Pattern
US Nationwide distribution.
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