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.
FDA Recall Z-0235-2015 · Posted 2014-11-20
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPQ
Date Initiated2014-10-10
Date Terminated2017-06-29
Product Quantity6
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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