Events

Recall of Device Recall BrainLAB Target Positioner for Leksell Headring

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
    38170
  • Event Risk Class
    Class 2
  • Event Number
    Z-1010-2007
  • Event Initiated Date
    2007-06-05
  • Event Date Posted
    2007-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53091
  • 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
    Radiation therapy treatment Target Positioner - Product Code IWY
  • Reason
    Target alignment error : a mechanical component/software incompatibility caused by a specific combination of the brainlab target positioner version 40700-3a for leksell headrings and brainlab planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.
  • Action
    BrainLAB immediately notified all customers with the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring, via e-mail on June 5, 2007. The Urgent Medical Device Product Notification letter dated June 4, 2007 included in the e-mail informed the customers that both the BrainSCAN and iPlan RT Dose treatment planning software calculates the isocenter position printed on the Target Positioner Overlays shifted 1.25 mm in cranial direction from the intended position, when the BrainLAB Target Positioner for Leksell Headring Revision A is used. The customers were instructed to cease using the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring for treatment planning and patient set-up. An updated target positioner will be provided to the customers to correct the problem, estimated to be available in September 2007. Any questions were directed to their local BrainLAB Customer Support Representative or CAPA Manager Markus Hofman at 49-89-99-15-68-44 or 1-800-597-5911 in the U.S.

Device

Device Recall BrainLAB Target Positioner for Leksell Headring
  • Model / Serial
    Catalog/version number 40700-3A, all serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Ohio, Washington and France
  • Product Description
    BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany; catalog/version number 40700-3A
  • Manufacturer
    Brainlab AG

Manufacturer

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