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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SimView NT and SimView NT with IDI

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  Class 2 Device Recall Siemens SimView NT and SimView NT with IDI see related information
Date Initiated by Firm October 10, 2014
Date Posted November 20, 2014
Recall Status1 Terminated 3 on June 29, 2017
Recall Number Z-0235-2015
Recall Event ID 69601
510(K)Number K953233  
Product Classification System, simulation, radiation therapy - Product Code KPQ
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.
Code Information Model numbers: 5496992, 5497016   with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPQ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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