SIEMENS brand ARTISTE syngo RT Therapist — Class II medical device recall Z-0907-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-03-13. Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo R
| Recall number | Z-0907-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Concord, CA, United States |
| Recall initiated | 2013-01-17 |
| Classified | 2013-03-05 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2013-03-05 |
| Countries outside the US | DE |
| Quantity | 5 units |
| Reason classes | software |
| Model numbers | 08162815 |
Product
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
Reason for recall
Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
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-0907-2013. 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.