FDA Device recall Z-0106-2016
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image revie…
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image revie… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0106-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-11 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | MA, MO, OH, PA, UT, WI |
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
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.
Identifiers
| code_info | Model Number of device- 10568604, serial numbers: 10206 10337 10338 10100 10289 10197 10131 10179 10184 10158 10235 10236 10080 10296 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0106-2016%22
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