Date Initiated by Firm | December 01, 2011 |
Date Posted | January 17, 2012 |
Recall Status1 |
Terminated 3 on December 02, 2013 |
Recall Number | Z-0798-2012 |
Recall Event ID |
60697 |
510(K)Number | K882729 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product | Mevatron KDS-2;
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 9822693, all units |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 4040 Nelson Ave Concord CA 94520-1200
|
For Additional Information Contact | Ghada 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 |
Action | Siemens 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 Commerce | 327 Active Devices - all models |
Distribution | Worldwide Distribution - USA (nationwide) |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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