Z-1182-2013Class II

Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT...

Name: Z-1182-2013 Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-04-04
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-04-04 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems... on 2013-04-04. FDA classified it as Class II and gives the reason as "Software update to fix multiple safety related issues". 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-1182-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2013-04-26
Terminated: 2013-08-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS 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: Software update to fix multiple safety related issues.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent updated instructions of TH004/13/S on April 4, 2013. The SW Update will be delivered by the Siemens Customer Service Group. For questions regarding this recall call 925-293-5442.
Quantity in commerce: 245 active devices
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa.
Product codes and lots: Syngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1182-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1182-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-26

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