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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ARTISTE, ONCOR and PRIMUS systems.

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  Class 2 Device Recall Siemens ARTISTE, ONCOR and PRIMUS systems. see related information
Date Initiated by Firm April 04, 2013
Date Posted April 26, 2013
Recall Status1 Terminated 3 on August 12, 2013
Recall Number Z-1182-2013
Recall Event ID 64944
510(K)Number K103606  K060226  K993425  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108
on Siemens ARTISTE, ONCOR and PRIMUS systems.

ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Code Information Syngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
757 Arnold Dr Ste A
Martinez CA 94553-3615
For Additional Information Contact Christine Dunbar
925-293-5442
Manufacturer Reason
for Recall		 Software update to fix multiple safety related issues.
FDA Determined
Cause 2		 Software design
Action Siemens sent updated instructions of TH004/13/S on April 4, 2013. The SW Update will be delivered by the Siemens Customer Service Group. For questions regarding this recall call 925-293-5442.
Quantity in Commerce 245 active devices
Distribution Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa.
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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