Z-1013-2015Class II

Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear...

Name: Z-1013-2015 Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-01-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-01-02 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and... on 2015-01-02. FDA classified it as Class II and gives the reason as "Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient...". 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-1013-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-02
Posted: 2015-01-26
Terminated: 2015-09-10
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.
Root cause tag: software
FDA root cause: Software Design Change
Action: A customer advisory notice, dated January 2, 2015, was sent to end users which identified the product, problem, and action to be taken. It was recommended that customers use only manual registration with the 6 degrees of freedom option disabled, which provides the correct offset values. A software update will be deployed once a solution is available.
Quantity in commerce: 3
Distribution: UT, WI, NY
Product codes and lots: model # 08162815, serial #s 10010, 10046, 10586

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1013-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1013-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-26

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)