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U.S. Department of Health and Human Services

Class 2 Device Recall BrainLab m3 MicroMultileafCollimator for Elekta/Philips Type III with MLC

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 Class 2 Device Recall BrainLab m3 MicroMultileafCollimator for Elekta/Philips Type III with MLCsee related information
Date Initiated by FirmMarch 19, 2009
Date PostedJuly 02, 2009
Recall Status1 Terminated 3 on August 19, 2010
Recall NumberZ-1547-2009
Recall Event ID 51484
510(K)NumberK004022 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductBrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany. The m MLC 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 41600-6A; Serial Number 41600-6A/24143.
Recalling Firm/
Manufacturer		 Brainlab AG
Ammerthalstrasse 8
Kirchheim B. Muenchen Germany
For Additional Information ContactMs. 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
ActionBrainLAB 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 Commerce1 unit
DistributionNationwide 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 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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