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U.S. Department of Health and Human Services

Class 2 Device Recall COHERENCE RT Therapist

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  Class 2 Device Recall COHERENCE RT Therapist see related information
Date Initiated by Firm March 05, 0013
Date Posted April 02, 2013
Recall Status1 Terminated 3 on August 28, 2014
Recall Number Z-1036-2013
Recall Event ID 64675
510(K)Number K123812  K092145  K060226  K993425  
Product Classification Accelerator, linear, medical - Product Code IYE
Product SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators;

Model:
COHERENCE AG TH, Part No. 5863506,
Current R630;

Product Usage:
The intended use of the SIEMENS branded 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 All units of these models.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
757 Arnold Dr Ste A
Martinez CA 94553-3615
For Additional Information Contact Christine Dunbar
925-602-8157
Manufacturer Reason
for Recall		 Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters". 9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out 10/18/2013; Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released
Quantity in Commerce 621 units (foreign account) in total
Distribution Worldwide Distribution
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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