Z-0106-2016Class II

Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization...

Name: Z-0106-2016 Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-08-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-08-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and... on 2015-08-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0106-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-11
Posted: 2015-10-06
Terminated: 2016-12-07
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Siemens, sent Recall letters, dated August 2015, that describe the product, the problem, and correction, will be hand-delivered to affected sites at the time the fix is implemented by a Siemens technician. If you have any questions, contact Regulatory Technical Specialist at 610-448-6471 or email: [email protected]
Quantity in commerce: 14
Distribution: US Distribution to states of: MA, MO, OH, PA, UT, and WI.
Product codes and lots: Model Number of device- 10568604, serial numbers: 10206 10337 10338 10100 10289 10197 10131 10179 10184 10158 10235 10236 10080 10296

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0106-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0106-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-06

Product code IYE

K142434Class IIArtiste Solution, Sys_vc10c, Phase 2 Update with the Syngo Rt Therapist & Rt Oncologist Workspaces, V4.3.1_mr1Siemens Medical Solutions USA, Inc. / cleared 2014-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)