Events

Recall of Device Recall BrainLab m3 MicroMultileafCollimator for Siemens Mevatron Digital Type III with MLC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brainlab AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51484
  • Event Risk Class
    Class 2
  • Event Number
    Z-1546-2009
  • Event Initiated Date
    2009-03-19
  • Event Date Posted
    2009-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82384
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    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.
  • 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).

Device

Device Recall BrainLab m3 MicroMultileafCollimator for Siemens Mevatron Digital Type III with MLC
  • Model / Serial
    Model 41600-5A; Serial Number 05-46974-41600-5A.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC, model 41600-5, -5 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.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Address
    Brainlab AG, Ammerthalstrasse 8, Kirchheim B. Muenchen Germany
  • Source
    USFDA