Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany
Lot Codes / Batch Numbers
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.
Products Sold
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.
Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany is recalling BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG, Kap due to The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multil. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026