SOMATOM Definition AS — Class II medical device recall Z-2268-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-08-21, distributed nationwide. Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A
| Recall number | Z-2268-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2019-07-03 |
| Classified | 2019-08-14 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2024-05-10 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Serial numbers | 64051, 64218, 64516, 65145, 65299, 65370, 65493, 66032, 66062, 66649, 92243, 92254, 92261, 92277, 92280, 92288, 92296, 92298, 92300, 92307, 92313, 92315, 92321, 92323, 92335 and 4 more |
| Model numbers | 8098027 |
Product
SOMATOM Definition AS, Model Number 8098027 - 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2268-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.