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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ARTISTE and ONCOR linear accelerator

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 Class 2 Device Recall Siemens ARTISTE and ONCOR linear acceleratorsee related information
Date Initiated by FirmNovember 09, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on April 15, 2013
Recall NumberZ-0459-2012
Recall Event ID 60525
510(K)NumberK060226 K103505 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
Code Information Artiste MV system, part number 8139789 ONCOR Impression PLUS, part number 5857912
FEI Number 2937457
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information ContactChristine Dunbar
925-602-8157
Manufacturer Reason
for Recall		Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.
FDA Determined
Cause 2		Component design/selection
ActionSiemens Medical Solutions USA, Inc. sent a Customer Information letter dated November 9, 2011, by federal express. The letter identified the product the problem and the action needed to be taken by the customer. The HW Update included information regarding the potential problem and provide instructions in the Safety update. Further questions call (925) 602-8157.
Quantity in Commerce13 active devices
DistributionWorldwide Distribution-- USA ( nationwide ) including the states of : MO, NC, OH, and OK and the countries of Turkey, Japan, Germany and Portugal
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
510(K)s with Product Code = IYE
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