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Class 2 Device Recall Siemens mMLC (ModuLeaf) |
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Date Initiated by Firm |
February 07, 2012 |
Date Posted |
March 07, 2012 |
Recall Status1 |
Terminated 3 on August 14, 2012 |
Recall Number |
Z-1184-2012 |
Recall Event ID |
61237 |
510(K)Number |
K030609
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Product Classification |
Block, beam-shaping, radiation therapy - Product Code IXI
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Product |
Siemens mMLC (ModuLeaf) safety bar and trolley label.
Siemens Medical Solutions USA, Inc. Concord, CA.
The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue. |
Code Information |
ModuLeaf, 110V/60Hz, part number 7334043; ModuLeaf, 220V/60Hz, part number 7334050. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 4040 Nelson Ave Concord CA 94520-1200
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For Additional Information Contact |
Adrianna Azevedo 925-602-8175
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Manufacturer Reason for Recall |
This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm, SIEMENS, issued a "Customer Information" letter to its customers. The letter described the product, problem and actions to be taken. Siemens developed a new steel knob that complies with the latest standards; Siemens checked all ModuLeaf mMLC trolleys and if necessary refitted with the safety label and also arranged for an inspection and modification of the customers system- a Release of the safety update UI TH 026/11/S to distribute and hardware update commenced on February 7, 2007 by certified mail.
If you have any questions, contact the Regulatory Specialist II at 925-602-8175. |
Quantity in Commerce |
46 active devices |
Distribution |
Worldwide distribution: USA (nationwide) including states of: CO, IA, KY, NJ, OH and TX; and countries of: Algeria, Austria, Belgium, Brazil, China, Egypt, France, Germany, Hungary, India, Italy, Japan, Kuwait, Malaysia, Mexico, P.R., Russian Fed., Saudi Arabia, South Africa, Spain, Turkey, and United Kingdom. |
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 = IXI and Original Applicant = MRC SYSTEMS GMBH
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