Z-1545-2009

BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG...

Name: Z-1545-2009 BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG...
Creator: Brainlab AG
Published: 2009-03-19
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2009-03-19 / Terminated

FDA source

Brainlab AG began a recall of BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany. The mMLC is... on 2009-03-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1545-2009
Status: Terminated
Initiated: 2009-03-19
Posted: 2009-07-02
Terminated: 2010-08-19
Recalling firm: Brainlab, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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 root cause: 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.
Product codes and lots: 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.

Product code IYE

K004022Class IIM3 (Mirco-Multileaf CollimatorBrainlab AG / cleared 2002-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)