Z-2073-2012Class II

ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and...

Name: Z-2073-2012 ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-06-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-06-25 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and... on 2012-06-25. FDA classified it as Class II and gives the reason as "Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT...". 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-2073-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-25
Posted: 2012-07-24
Terminated: 2012-10-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist 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 delivered by the Siemens Customer Service Group or by certified mail to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm stated that release of this UI TH018/12/S to distribute the notifications began on June 25, 2012.
Quantity in commerce: 18
Distribution: Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.
Product codes and lots: ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472, ONCOR Impression Plus, Part #: 05857912, ONCOR Expression, Part #: 07360717

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2073-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2073-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-24

Product code IYE

K103606Class IIArtiste Solution with Sys_vb50 UpdateSiemens Medical Solutions USA, Inc. / cleared 2011-04-15

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)