Z-1523-2011

Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to...

Name: Z-1523-2011 Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to...
Creator: Siemens Medical Solutions USA, Inc
Published: 2010-06-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-06-29 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens... on 2010-06-29. The reason FDA records is "A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment". 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-1523-2011
Status: Terminated
Initiated: 2010-06-29
Posted: 2011-03-04
Terminated: 2012-03-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist version 4.1 Connected to MOSAIQ, Part No. 8168754, Distributed by Siemens Medical Solutions Oncology Care System, Concord CA Medical charged-particle radiation therapy system. 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: A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.
Root cause tag: software
FDA root cause: Other
Action: Siemens sent Urgent Medical Device Correction, Safety Advisory Notices to all affected customers on June 29, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their System Owner Manual, Chapter, "Safety Advisory Letter. For questions customers were instructed to contact their Siemens Service Engineer or Application Specialist. For questions regarding this recall call 925-602-8157.
Distribution: Worldwide Distribution - USA including NC,OH, and the countries of Belgium, Sweden, Germany, Lebanon, Japan, Australia, and Iran.
Product codes and lots: All codes.

Product code IYE

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)