FDA Device recall Z-1919-2019
SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syste…
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography syste… by Siemens Medical Solutions Usa, citing the potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1919-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-04 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM go.Up, Model No. 11061628 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
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
Identifiers
| code_info | 108128 108101 108158 108164 108118 108112 108163 108183 108133 108170 108096 108114 108154 108168 108144…108128 108101 108158 108164 108118 108112 108163 108183 108133 108170 108096 108114 108154 108168 108144 108120 108136 108174 108106 108099 108113 108177 108080 108126 108153 108088 108085 108115 108100 108175 108076 108109 108127 108108 108176 108059 108054 108179 108125 108116 108056 108077 108155 108069 108146 108062 108130 108095 108111 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1919-2019%22
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