FDA Device recall Z-2273-2019
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional imag…
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional imag… 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-2273-2019 |
| 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 Edge Plus, Model Number 10267000 - 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: 122022 122020 122008 122036 122029 122044 122037 122009 122038 122035 122041 122011 122034 122004 |
|---|
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-2273-2019%22
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