Device Recall Brainlab

  • 모델명 / 제조번호(시리얼번호)
    Model/Catalog Number: 19061-03
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) including states of: NC, NY, OH, WI;and countries of: Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia.
  • 제품 설명
    Navigation Spine & Trauma 3D Version 2.0 and 2.1 || Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. || The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Model 52856 BL CURVED CUP INSERTER UNIVERSAL SHAFT; and MODEL 52856A BL OFFSET CUP IMPACTOR UNIVERSAL SHAFT, all serial/lot numbers distributed prior to January 13, 2015.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US: Nationwide (AZ, CA, ID, IL, MD, MI, MN, OH, OK, OR, TN, WA, WI, WV); Australia, Austria, Bahrain, Belgium, Germany, Hong Kong, India, Italy, Japan, Malaysia, Russian Federation, Saudi Arabia, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom
  • 제품 설명
    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0.   Model/Catalog Numbers:   49971, CBCT IMPORT & ALIGNMENT SOFTWARE;  20836, EXACTRAC 6.0 VARIAN CBCT LICENSE;   The software may be contained in configured items:   48320, ET UPGRADE SOFTWARE 6.0 TO 6.1;  48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA;  49973B, ET DATA PREP / REVIEW SYSTEM;  49973A, ET DATA PREP / REVIEW SYSTEM;  49973, ET DATA PREP / REVIEW SYSTEM;  49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT;  48302, ET DATA PREP / REVIEW SYSTEM
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.
  • 제품 설명
    ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Software Versions: ExacTrac v. 6.x (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0);   Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE;  48320, ET UPGRADE SOFTWARE 6.0 TO 6.1;  48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA;  49973B, ET DATA PREP / REVIEW SYSTEM;  49973A, ET DATA PREP / REVIEW SYSTEM;  49973, ET DATA PREP / REVIEW SYSTEM;  49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT;  48302, ET DATA PREP / REVIEW SYSTEM
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland
  • 제품 설명
    ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model/catalogue numbers: 19060 AIR ICT S&T; W/O G.C. NEUROLOGICA BODYTOM; 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL. Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the US and Australia.
  • 제품 설명
    BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.
  • Manufacturer
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