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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo RT Therapist and syngo RT Oncologist

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  Class 2 Device Recall Siemens syngo RT Therapist and syngo RT Oncologist see related information
Date Initiated by Firm June 17, 2014
Date Posted August 10, 2014
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-2180-2014
Recall Event ID 68634
510(K)Number K072485  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Code Information Syngo RT Therapist (RTT 4.3.SP1) - model no. 08162815 Syngo RT Oncologist (RTO 4.3.SP1) - model no. 10568604 Syngo RT Therapist (RTT 4.3.SP1) for U.S. affected units only:  10010 10046 10586  No Syngo RT Oncologist (RTO 4.3.SP1) listed for U.S. 
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 potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.
FDA Determined
Cause 2		 Software design
Action In June, 2014, an urgent medical device correction field safety notice of improvement was sent to end users informing them of the product, problem, and action to be taken to avoid the potential safety issue.
Quantity in Commerce 56
Distribution UT, WI, NY
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 = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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