Events

Recall of Device Recall Brainlab Diital Lightbox

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
    68737
  • Event Risk Class
    Class 2
  • Event Number
    Z-2134-2014
  • Event Initiated Date
    2014-06-27
  • Event Date Posted
    2014-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128583
  • 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
    System, image processing, radiological - Product Code LLZ
  • Reason
    The following defects have been identified for data loaded with patient data manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) when loading non-square pixel image data with pdm 2.0, the data set is not correctly transferred and displayed in the corresponding brainlab navigation or planning software. when a data set is loaded, the pixels of the data set are sorted in order to.
  • Action
    FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated June 27, 2014 were sent to all direct accounts. The letters instruct product users to not upload image data sets with non-square pixels and to verify with their radiology department the modalities of the different imaging devices (e.g. CT, MRT, PET, ultrasound) from which data may be loaded onto a Brainlab device. Brain lab will provide a software update with this issue solved to affected customers with a tentative planned time line of availability being July 2014. Customers with questions can contact Brainlab by telephone at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall Brainlab Diital Lightbox
  • Model / Serial
    Model/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2.   Software Versions: 2.0.0, 2.0.1, and 2.0.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AK, AZ, CA, FL, GA, IA, IL, KS, MD, MO, MS, NC, NY, OH, PA, SD, TX, VA, VT, WA, and WI, and the countries of Australia, Austria, Belgium, Brazil, Chile, China, Ecuador, France, Germany, Japan, Netherlands, New Zealand, Norway, Qatar, Russia, Spain, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
  • Product Description
    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Address
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    USFDA