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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo RT Therapist

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  Class 2 Device Recall Syngo RT Therapist see related information
Date Initiated by Firm January 02, 2015
Date Posted January 26, 2015
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-1013-2015
Recall Event ID 70200
510(K)Number K142434  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Code Information model # 08162815, serial #s 10010, 10046, 10586
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.
FDA Determined
Cause 2		 Software Design Change
Action A customer advisory notice, dated January 2, 2015, was sent to end users which identified the product, problem, and action to be taken. It was recommended that customers use only manual registration with the 6 degrees of freedom option disabled, which provides the correct offset values. A software update will be deployed once a solution is available.
Quantity in Commerce 3
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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