Z-1064-2011

Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express...

Name: Z-1064-2011 Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express...
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-07-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-07-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express... on 2009-07-30. The reason FDA records is "Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those...". 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-1064-2011
Status: Terminated
Initiated: 2009-07-30
Posted: 2011-02-08
Terminated: 2011-04-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. Intended use: medical charged-particle radiation therapy system
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential for Mistreatment-- when treatment plans intended for non-ARTISTE machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.
Root cause tag: software
FDA root cause: Software design
Action: The firm,Siemens, sent two Customer Advisory letters (TH004/09/S and TH008/09/S) contained in the Update Instructions to all consignees/customers with active devices. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow the updated instructions. Siemens service representative will sign a document noted as CORRECTED upon completion of the software installation. If you have any questions, call 1-925-602-8157.
Quantity in commerce: 151 units
Distribution: Worldwide distribution: USA and countries including: Germany, France, Poland, Norway, Australia, Malaysia, Spain, New Zealand, the UK, India, Republic of Korea, Canada, Ireland, Italy, Egypt, Belgium, Philippines, Saudi Arabia, Netherlands, Hungary, Norway and South Africa.
Product codes and lots: Artiste MV system Part Number 8139789. RT Therapist Part Number 8162815, Therapist Express Basic part number 8151289. Optional parts: Syngo RT Therapist assist part number 8162807, Therapist Express Assist part number 8151297.

Product code IYE

K072485Class IIArtiste Mv SaSiemens Medical Solutions USA, Inc. / cleared 2007-12-27

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)