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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE MV with Artiste Digital Linear Accelerators

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 Class 2 Device Recall ARTISTE MV with Artiste Digital Linear Acceleratorssee related information
Date Initiated by FirmDecember 03, 2010
Date PostedFebruary 24, 2011
Recall Status1 Terminated 3 on June 30, 2011
Recall NumberZ-1422-2011
Recall Event ID 57704
510(K)NumberK072485 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductSiemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; Intended use: To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA; and Siemens Medical Solutions AG, Roentgenstrasse, Kemnath, Germany, and Siemens Medical Solutions AG, Henkestrasse, Erlangen, Germany
Code Information Serial No. 5647 - 5718  (Specifically 5647,5651,5652,5660,5657, 5664,  5654,5686,5687,5688,5689, 5606,  5690,5700,5701,5699,5704,5705,5707,5708,  5714, 5716, and 5718) 
FEI Number 2937457
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc., Concord, CA
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information ContactChristine Dunbar
925-246-8407
Manufacturer Reason
for Recall		The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.
FDA Determined
Cause 2		Other
ActionThe firm, Siemens, issued a "Customer Information" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' . If you any questions, please call 925-246-8407.
Quantity in Commerce20 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
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