Syngo RT Oncologist — Class II medical device recall Z-0106-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-10-14, distributed in MA, MO, OH, PA, UT, WI. This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running S
| Recall number | Z-0106-2016 |
|---|---|
| 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 | 2015-08-11 |
| Classified | 2015-10-06 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-12-07 |
| Distributed | MA, MO, OH, PA, UT, WI |
| Quantity | 14 |
| Reason classes | software |
| Serial numbers | 10080, 10100, 10131, 10158, 10179, 10184, 10197, 10206, 10235, 10236, 10289, 10296, 10337, 10338 |
Product
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.
Reason for recall
This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safety Notice distributed as UFSN-RTT/RTO 4.3 Adaptive Targeting [Auto-registration]. The update contains several important safety and performance fixes.
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-0106-2016. 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.