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U.S. Department of Health and Human Services

Class 2 Device Recall MEVATRON

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 Class 2 Device Recall MEVATRONsee related information
Date Initiated by FirmDecember 01, 2011
Date PostedJanuary 17, 2012
Recall Status1 Terminated 3 on December 02, 2013
Recall NumberZ-0781-2012
Recall Event ID 60697
510(K)NumberK882729 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMevatron K2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Code Information Part number 1940753, all units
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information ContactGhada Trotabas
925-602-8157
Manufacturer Reason
for Recall		Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSiemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.
Quantity in Commerce327 Active Devices - all models
DistributionWorldwide Distribution - USA (nationwide)
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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