Z-0907-2013Class II

SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear...

Name: Z-0907-2013 SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-01-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-01-17 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by... on 2013-01-17. FDA classified it as Class II and gives the reason as "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...". 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-0907-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-17
Posted: 2013-03-05
Terminated: 2013-03-05
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued "Urgent Medical Device Correction" letters via mail to all its direct consignees, informing them of the affected product issue and providing instructions on the recall. The firm stated that the release of this UI TH005/13/S to distribute the Customer Safety Advisory Notice began on January 17, 2013.
Quantity in commerce: 5 units
Distribution: 5 devices, all located outside of the United States in Germany.
Product codes and lots: All codes/units of ARTISTE model.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0907-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0907-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-05

Product code IYE

K121295Class IIArtistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. / cleared 2012-06-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)