Z-2270-2019 Class II Terminated
FDA device recall Z-2270-2019 was initiated by Siemens Medical Solutions USA, Inc on July 3, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 10, 2024). Affected quantity: N/A.
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 Flash, Model Number 10430603 - 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: 73008 98642