Z-0235-2015Class II

Siemens SimView NT and SimView NT with IDI simulation system components

Name: Z-0235-2015 Siemens SimView NT and SimView NT with IDI simulation system components
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-10-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-10-10 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for... on 2014-10-10. FDA classified it as Class II and gives the reason as "Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection...". 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-0235-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-10
Posted: 2014-11-20
Terminated: 2017-06-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.
Product code: KPQ System, Simulation, Radiation Therapy
Reason for recall: Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were initially notified about the issue by letter on January 7, 2014 (this action was reported as Z-0786-2014 which has been terminated). Siemens promised to notify them when a fix became available. Customer letter, dated November 7, 2014, was sent to notify end users that a fix has become available and Siemens would contact them to schedule an appointment for the correction.
Quantity in commerce: 6
Distribution: Worldwide Distribution - US Nationwide in the states of PA, KY, LA, MA, MI, and CA; and countries of: Argentina, Belarus, Bulgaria, Costa Rico, P.R. China, Curacao, Egypt, Repulic Korea, Germany, Greece, Hungary, Italy, Iraq, Jordan, Malaysia, Palestanian Ter, Poland, Thailand, Turkey, and Vietnam.
Product codes and lots: Model numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0235-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0235-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-19

Product code KPQ

K953233Class IISimview 3000 CT OptionSiemens Medical Solutions USA, Inc. / cleared 1996-11-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)