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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo RT Dosimetrist 2.7 system

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  Class 2 Device Recall Siemens syngo RT Dosimetrist 2.7 system see related information
Date Initiated by Firm May 15, 2014
Date Posted July 17, 2014
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-2075-2014
Recall Event ID 68395
510(K)Number K101119  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
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.
Code Information material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272 
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		 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
FDA Determined
Cause 2		 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.
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 = MUJ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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