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U.S. Department of Health and Human Services

Class 2 Device Recall SIEMENS ARTISTE

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  Class 2 Device Recall SIEMENS ARTISTE see related information
Date Initiated by Firm May 29, 2013
Date Posted June 21, 2013
Recall Status1 Terminated 3 on November 26, 2013
Recall Number Z-1562-2013
Recall Event ID 65435
510(K)Number K121295  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ARTISTE with syngo RT Therapist version 4.3

Product Usage:
The intended use of the SIEMENS branded ARTISTE 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 the version 4.3, Part No. 08162815
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		 The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.
FDA Determined
Cause 2		 Device Design
Action Siemens sent an Urgent: Medical Device Correction Customer Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem, what preventive measures can the user take and actions to be taken. Customers were advised to perform the preventive measures provided and inform all affected personnel immediately. The letter states that Siemens is currently working on a new version of the software. Customers are asked to include the Customer Safety Advisory Notice in the System Owner Manual chapter "Safety Advisory Letters". For question call 925-602-8157.
Quantity in Commerce 8 units
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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