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Class 2 Device Recall Siemens ARTISTE, ONCOR and PRIMUS systems. |
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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
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Product Classification |
Accelerator, linear, medical - Product Code IYE
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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
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For Additional Information Contact |
Christine Dunbar 925-293-5442
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Manufacturer Reason for Recall |
Software update to fix multiple safety related issues.
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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
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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