Events

Recall of Device Recall Brainlab

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
    69960
  • Event Risk Class
    Class 2
  • Event Number
    Z-0956-2015
  • Event Initiated Date
    2014-11-19
  • Event Date Posted
    2015-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132036
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    Iplan rt radiation treatment planning software: potentially incorrect patient positioning when using multiple localized ct image data sets.
  • Action
    Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 19, 2014, to all affected customers. The letter included instructions to: 1) If clinically not required, do not use multiple localized CT scans within one treatment plan (to avoid potentially incorrect Reference and Alignment Set assignments in the first place). 2) If you must use multiple localized CT scans, e.g. for recurrent treatment planning of the same patient, always guarantee that the latest (see note *) CT scan is defined as both Alignment Set and Reference Set during treatment planning. Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers tentatively starting January 2016 to schedule the update. Brainlab will additionally refine the instructions for use of the iPlan RT treatment planning software in regard to implications of Alignment Set and Reference Set selections and will provide this user guide update to existing affected customers together with the software update. Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall Brainlab
  • Model / Serial
    Software Versions:   1) 21213 IPLAN RT DOSE 3.0 PLATFORM;  2) 21213A IPLAN RT DOSE 3.0.1 PLATFORM;  3) 21213B IPLAN RT DOSE 3.0.2 PLATFORM;  4) 21213D IPLAN RT DOSE 4.1.0 PLATFORM;  5) 21213E IPLAN RT DOSE 4.1.1 PLATFORM;  6) 21213F IPLAN RT DOSE 4.1.2 PLATFORM;  7) 21213G IPLAN RT DOSE 4.1.3 PLATFORM;  8) 21213H IPLAN RT DOSE 4.1.4 PLATFORM;  9) 21381 IPLAN RT DOSE 4.5.0 PLATFORM;  10) 21381A IPLAN RT DOSE 4.5.1 PLATFORM;  11) 21381B IPLAN RT DOSE 4.5.2 PLATFORM;  12) 21381C IPLAN RT DOSE 4.5.3 PLATFORM;  13) 21385 UPGRADE IPLAN RT DOSE 4.X TO 4.5.0;  14) 21385A UPGRADE IPLAN RT DOSE 4.X TO 4.5.1;  15) 21385B UPGRADE IPLAN RT DOSE 4.X TO 4.5.2;  16) 21385C UPGRADE IPLAN RT DOSE 4.X TO 4.5.3;  17) 21387 iPLAN RT DOSE PLATFORM 4.1 (21213);  18) 21387A iPLAN RT DOSE PLATFORM 4.1.2 (21213);  19) 21387B iPLAN RT DOSE PLATFORM 4.5.1 (21381);  20) 21387C iPLAN RT DOSE PLATFORM 4.5.2 (21381);  21) 21387D IPLAN RT DOSE PLATFORM 4.5.3(21381) V;  22) 70213 UPGRADE BRAINSCAN 5.X TO iPLAN RT DOSE 3;  23) 70213A UPGRADE BRAINSCAN 5.X TO iPLAN RT DOSE 3;  24) 70213B UPG BRAINSCAN 5.X TO iPLAN RT DOSE 3.0;  25) 70213C UPG BRAINSCAN 5.X TO iPLAN RT DOSE4.1.0;  26) 70213D UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.1.1;  27) 70213E UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.1.2;  28) 70213F UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.5.1;  29) 70214 UPGRADE BRAINSCAN 3.X/ 4.X TO IPLAN RT D;  30) 70214A UPGRADE BRAINSCAN 3.X/ 4.X TO IPLAN RT D;  31) 70214B UPG BRAINSC 3.X/4.X TO IPLAN RT DOSE 3.0;  32) 70214C UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.0;  33) 70214D UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.1;  34) 70214E UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.2;  35) 70214F UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.5.1;  36) 70226 UPGRADE IPLAN RT DOSE 3.0 TO 3.0.1;  37) 70226A UPGRADE IPLAN RT DOSE TO 3.0.2;  38) 70228 UPGRADE IPLAN RT DOSE 3.X TO 4.0;  39) 70228A UPG IPLAN RT DOSE 3.X TO 4.1.0;  40) 70228B UPG IPLAN RT DOSE 3.X TO 4.1.1;  41) 70228C UPG IPLAN RT DOSE 3.X TO 4.1.2;  42) 70228D UPG IPLAN RT DOSE 3.X TO 4.5.1;  43) 70228E UPG IPLAN RT DOSE 3.X TO 4.5.2;  44) 70228F UPG IPLAN RT DOSE 3.X TO 4.5.3;  45) 70235 UPGRADE BRAINSCAN TO IPLAN RT DOSE 4.5;  46) 70235A UPGRADE BRAINSCAN TO IPLAN RT DOSE 4.5.2;  47) 70235B UPGRADE BRAINSCAN TO IPLAN RT DOSE 4.5.3;  48) 70237 UPD IPLAN RT DOSE 4.x TO 4.5 (0TRANSFER);  49) 70237A UPD IPLAN RT DOSE 4.x TO 4.5.2 (O TRANS);  50) 70237B UPD IPLAN RT DOSE 4.x TO 4.5.3(O TRANS);  51) 70263 UPD IPLAN RT DOSE 4.1.x to 4.1.3.(0TRA);  52) 70440 UPD iPLAN RT DOSE 4.1.0 TO 4.1.1;  53) 70440A UPD iPLAN RT DOSE 4.1 TO 4.1.2;  54) 20146 2ND LICENCE SW - FOR ONE ADDITIONAL WS;  55) 20147 RT SRS 2ND LICENCE SW FOR ONE ADD SITE;  56) 20148 NOVALIS TX 2ND LICENCE SW ONE ADD SITE
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, Wyoming and Internationally to Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, and Venezuela.
  • Product Description
    iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
  • Manufacturer
    Brainlab AG

Manufacturer

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