Events

Rappel de Device Recall Brainlab

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Brainlab AG.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69960
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0957-2015
  • Date de mise en oeuvre de l'événement
    2014-11-19
  • Date de publication de l'événement
    2015-01-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132038
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System,planning,radiation therapy treatment - Product Code MUJ
  • Cause
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Société-mère du fabricant (2017)
    Brainlab AG
  • Source
    USFDA