Class 2 Device Recall Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122

• Date Initiated by Firm: October 23, 2008
• Date Posted: January 29, 2009
• Recall Status: Terminated on December 09, 2010
• Recall Number: Z-0927-2009
• Recall Event ID: 50515
• 510(K)Number: K072485
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
• Code Information: Part Number 8139789, Serial Numbers: 5190, 5350, 5355, 5364, 5367, 5374, 5377, 5398, 5405, 5410, 5419, 5424, 5165, 5166, 5202, 5238, 5298, 5306, 5342, 5352, 5365, 5366, 5373, 5378, 5379, 5380, 5397, 5399, 5400, 5401, 5402, 5409, 5414, 5416, 5423 and 5425.
• 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: If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstanc
• FDA Determined Cause: Software design
• Action: An Urgent Medical Device Customer Safety Letter dated October 23, 2008 was issued to consignees via certified mail. The letter identified the issue and preventive measures for consignees. Monitoring will be done via return cards. Follow-up to be conducted via telephone.
• Quantity in Commerce: 36 units
• Distribution: Worldwide Distribution including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium, New Zealand, France, Malaysia, Spain, and Canada.
• 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