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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 Recall
COHERENCE RT Therapist
see related information
Date Posted April 02, 2013
Recall Status1 Terminated on August 28, 2014
Recall Number Z-1038-2013
Recall Event ID 64675
Premarket Notification
510(K) Numbers
K060226  K092145  K123812  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 Impression TH, Part No. 7341410, 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, California 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
DESIGN: 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 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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