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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 Recall
Siemens ARTISTE, ONCOR and PRIMUS systems.
see related information
Date Posted April 26, 2013
Recall Status1 Terminated on August 12, 2013
Recall Number Z-1182-2013
Recall Event ID 64944
Premarket Notification
510(K) Numbers
K060226  K103606  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, California 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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