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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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 Class 2 Device Recall Siemenssee related information
Date Initiated by FirmDecember 20, 2008
Date PostedJanuary 30, 2009
Recall Status1 Terminated 3 on December 09, 2010
Recall NumberZ-0949-2009
Recall Event ID 50787
510(K)NumberK072485 
Product Classification accelerator, linear - Product Code IYE
ProductArtiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord, CA Medical charged-particle radiation therapy system.
Code Information All units of Part Number: 8139789
FEI Number 2937457
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information ContactChristine Dunbar
925-246-8407
Manufacturer Reason
for Recall		The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.
FDA Determined
Cause 2		Device Design
ActionOn 12/20/08, the firm issued letters via certified mail to direct consignees, informing them of the affected product and providing instructions on the recall. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for additional information.
Quantity in Commerce43 units
DistributionNationwide and Worldwide
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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