Z-1922-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- June 4, 2019
- Termination Date
- March 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69
Product Description
SOMATOM go.Top, Model No. 11061648 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.
Reason for Recall
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Distribution Pattern
US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and WI
Code Information
119913