Z-1562-2013Class II

ARTISTE with syngo RT Therapist version 4.3

Name: Z-1562-2013 ARTISTE with syngo RT Therapist version 4.3
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-05-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-05-29 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver... on 2013-05-29. FDA classified it as Class II and gives the reason as "The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1562-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-29
Posted: 2013-06-21
Terminated: 2013-11-26
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE 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: The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an Urgent: Medical Device Correction Customer Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem, what preventive measures can the user take and actions to be taken. Customers were advised to perform the preventive measures provided and inform all affected personnel immediately. The letter states that Siemens is currently working on a new version of the software. Customers are asked to include the Customer Safety Advisory Notice in the System Owner Manual chapter "Safety Advisory Letters". For question call 925-602-8157.
Quantity in commerce: 8 units
Distribution: Worldwide distribution
Product codes and lots: All units of the version 4.3, Part No. 08162815

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1562-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1562-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-20

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