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U.S. Department of Health and Human Services

Class 2 Device Recall Artiste MV system

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  Class 2 Device Recall Artiste MV system see related information
Date Initiated by Firm July 04, 2008
Date Posted October 20, 2008
Recall Status1 Terminated 3 on December 22, 2010
Recall Number Z-0116-2009
Recall Event ID 49024
510(K)Number K072485  
Product Classification Linear accelerator - Product Code IYE
Product Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.
Code Information All products with COHERENCE Therapist RTT4.1
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact
925-246-8407
Manufacturer Reason
for Recall		 Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.
FDA Determined
Cause 2		 Software change control
Action A letter marked "Urgent" dated July 4, 2008 was sent to customers. The letter provided a detailed description of the issues, the conditions under which these issues may occur, as well as recommendations to avoid these issues. Customer notification TH022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for assistance.
Quantity in Commerce 16
Distribution Nationwide in LA, WI, DE, PA and OH, and internationally in Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium and France
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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