Z-2075-2014Class II

Siemens syngo RT Dosimetrist 2.7 system

Name: Z-2075-2014 Siemens syngo RT Dosimetrist 2.7 system
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-05-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-05-15 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system... on 2014-05-15. FDA classified it as Class II and gives the reason as "An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name...". 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-2075-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Posted: 2014-07-17
Terminated: 2014-12-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken.
Quantity in commerce: 7
Distribution: US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.
Product codes and lots: material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2075-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2075-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-17

Product code MUJ

K101119Class IISyngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc. / cleared 2010-06-16

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)