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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE, ONCOR Avantgarde, Impression Plus, and Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist

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  Class 2 Device Recall ARTISTE, ONCOR Avantgarde, Impression Plus, and Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist see related information
Date Initiated by Firm August 05, 2015
Date Posted September 24, 2015
Recall Status1 Terminated 3 on September 01, 2016
Recall Number Z-2812-2015
Recall Event ID 71915
510(K)Number K103606  K090683  K993425  K060226  K031764  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer

Product Usage:
The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.
Code Information ARTISTE - 08139789 ONCOR Avantgarde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression  07360717 PRIMUS - K993425 PRIMUS Plus  04504200 Syngo RT Therapist - 08162815  serial numbers: 5177 3761 3981 3998 5096 70-4161 3354 10570 10793 10794 10796 10795 10798 10814 10792 5300 10046 10549 10687 3624 5350 5784 10586 5830 10010 5419 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Mail Code: 65-1A
Malvern PA 19355-1418
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Siemens sent Notification letters to affected customers. The letter identified the affected product, problem and actions to be taken. The letter advise customers that the software fix was rolled out to address multiple safety issues.
Quantity in Commerce 26
Distribution Worldwide Distribution and US Nationwide
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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