Z-3003-2011

ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany...

Name: Z-3003-2011 ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany...
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-06-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-06-03 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany. Distributed by Siemens Medical Solutions, Concord, CA... on 2011-06-03. The reason FDA records is "A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image". 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-3003-2011
Status: Terminated
Initiated: 2011-06-03
Posted: 2011-08-11
Terminated: 2012-02-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany. Distributed by Siemens Medical Solutions, Concord, CA 94520. Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an "Urgent: Medical Device Correction/ Customer Safety Advisory Notice" letter to all affected customers starting June 3, 2011. The letter describes the product, problem, and instructions to prevent mistreatment. The letter states that Siemens is working on an updated version of RTT 4.1 that will fix the issues. Users will be notified as soon as the update for the system is available. The customers were instructed to include Customer Safety Advisory notice in their syngo RT Therapist 4.1 System Owner Manual chapter "Safety Advisory Letters" where it should remain.
Quantity in commerce: 223 active devices
Distribution: Worldwide Distribution - USA (nationwide) including the states of: DE, FL, KY, LA, MA, MI, MO, NE, NJ, OH, PA, TN, WI, UT, WV and Puerto Rico and the countries of: Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hungary, India, Ireland, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Russian Fed, Saudi Arabia, South Africa, Norway, Spain, Turkey and United Kingdom.
Product codes and lots: Therapist Express Basic, Part Number 08151289; Therapist Express Assist, Part Number 08151297; syngo RT Therapist Assist, Part Number 08162807; syngo RT Therapist, Part Number 08162815; syngo RT Therapist Connect/MOSIAQ OIS, Part Number 08168754.

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)