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U.S. Department of Health and Human Services

Class 2 Device Recall BrainLab m3 MicroMultileafCollimator for Varian Type III with MLC

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  Class 2 Device Recall BrainLab m3 MicroMultileafCollimator for Varian Type III with MLC see related information
Date Initiated by Firm March 19, 2009
Date Posted July 02, 2009
Recall Status1 Terminated 3 on August 19, 2010
Recall Number Z-1545-2009
Recall Event ID 51484
510(K)Number K004022  
Product Classification Accelerator, linear, medical - Product Code IYE
Product BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany.

The mMLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation.
Code Information Model 41600-3; Serial Numbers: 06-99333-41600-3, 03-009-41600-3, 41600-3/35396, 41600-017, 41600-3/28593, 41600-064-00, 03-023-41600-3, 41600-056-99, 41600-075-00, 41600-060-00, 41600-3/36524, 05-55140-41600-3, 41600-059-99, 05-60360-41600-3, 41600-3/27334, 41600-078-00, 41600-3/21564, 03-024-41600-3, 41600-3/33271, 41600-022, 41600-3/34734, 41600-051, 41600-018, 03-011-41600-3, 01-033-41600, 41600-084-00, 01-038-41600, 41600-3/27296, 41600-026, 00-098-41600, 01-031-43500, 41600-3/20311, 41600-050, 41600-3/29308 and 41600-024 Refurbished to1848808001.  
Recalling Firm/
Manufacturer
Brainlab AG
Ammerthalstrasse 8
Kirchheim B. Muenchen Germany
For Additional Information Contact Ms. Kate Franco
800-597-5911
Manufacturer Reason
for Recall
The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment.
FDA Determined
Cause 2
Other
Action BrainLAB AG issued an "Urgent Field Safety Notice/Product Notification" letter dated March 19, 2009 informing all customers of the affected device. Consignees were instructed on proper steps to take to avoid further issues. In addition, the most current m3 mMLC user guide, version 7.4, was scheduled to be sent to users in April 2009. For further questions, contact BrainLAB AG by phone at 1-800-597-5911).
Quantity in Commerce 35 units
Distribution Nationwide Distribution - AL, CA, CO, FL, GA, IL, KS, KY, LA, MD, MI, MN, MS, ME, NJ, NY, OR, TN, TX, UT, VA, WV, WA and WI.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYE and Original Applicant = BRAINLAB AG
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