FDA Device recall Z-2272-2019
SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional ima…
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional ima… by Siemens Medical Solutions Usa, citing potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2272-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-03 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Confidence, Model Number 10590100 - 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
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Identifiers
| code_info | Serial Numbers: 100172 100091 100112 100143 100158 100191 100107 100157 100137 100190 100092 100129 100136…Serial Numbers: 100172 100091 100112 100143 100158 100191 100107 100157 100137 100190 100092 100129 100136 100189 100156 100117 100097 100099 100174 100073 100016 100182 100146 100170 100175 100090 100160 100087 100025 100165 100147 100046 100140 100085 |
|---|
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-2272-2019%22
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