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Manufacturers
Brainlab Australia Pty Ltd
제조사 모회사 (2017)
Brainlab AG
Source
DHTGA
32 Events
ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5 의 리콜
Brainlab Navigation System Spine & Trauma 3D 의 리콜
AIRO Mobile CT Scanner Model: MobiCT-32 의 리콜
AIRO Mobile CT ScannerModel Number: MobiCT-32 의 리콜
Brainlab Offset Cup Impactor Universal (blue handle) 의 리콜
iPlan RT, iPlan RT Dose and BrainSCANAll Software versions 의 리콜
Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base 의 리콜
iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional function Dose Planning for Agility Multileaf-Collimator (MLC) 의 리콜
Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis (AHSA) v1.0.0(Used for Linac based radiation treatment planning of cranial, head and neck, and extracranial lesions) 의 리콜
Brainlab Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0(Picture archiving and communication system (PACS) used in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions) 의 리콜
Brianlab iPlan RT Image (versions below v.4.1.2) / iPlan RT and BrainSCAN (discontinued in 2002) (Radiation therapy treatment planning system) 의 리콜
Brainlab Patient Data Manager(Used for the display of medical images or treatment / surgery plans from picture archiving and communication systems (PACS), file servers, or removable storage media) 의 리콜
Disposable Reflective Marker Spheres 의 리콜
EXACTRAC Version 6.0.0 through to 6.0.5 (Image Guided Radiation Therapy Patient Positioning System) 의 리콜
iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Software) 의 리콜
Brainlab Cranial Navigation System (all versions before Cranial 3.0) 의 리콜
Brainlab Navigation Software Spine & Trauma 3D versions 2.0 /2.1 and Navigation Software Cranial / ENT version 2.1 의 리콜
EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System) 의 리콜
Brainlab Offset Cup Impactor Universal 의 리콜
iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positioner, ExacTrac v.4.5 or v.5.x, ExacTrac Vero (versions 2.1, 3.0, 3.1, 3.1.1, 3.2.0, 3.2.1) 의 리콜
Brainlab Patient Data Manager 의 리콜
ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system) 의 리콜
ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient positioning system) 의 리콜
Instrument Star Unit ML (Calibration with ICM4) (part of Brainlab Spine & Trauma Navigation System) 의 리콜
BrainLab Navigation Software Spine and Trauma 3D 2.0 (intra-operative image guided stereotactic localisation system to enable precision spine and trauma surgeries) 의 리콜
Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator) 의 리콜
iPlan CMF 3.0, iPlan Cranial 3.0, iPlan ENT 3.0, iPlan Flow 3.0, iPlan spine 3.0, iPlan Stereotaxy 3.0 (including all subversions) 의 리콜
Brainlab Cranial Navigation System, all versions 의 리콜
iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planning system) 의 리콜
ExacTrac (Image guided radiation treatment therapy patient positioning system) 의 리콜
ExacTrac versions 6.0.1 and 6.0.2 only (Image Guided RadiationTherapy Patient Positioning System) 의 리콜
Standard Cranial Reference Array (used with Vector Vision Cranial Navigation System) 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 32 건
ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5
모델명 / 제조번호(시리얼번호)
ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5ARTG Number: 121226 (Brainlab Australia Pty Ltd - ExacTrac / Novalis Body - Patient positioning device, diagnostic imaging/radiotherapy, whole body)
Brainlab Navigation System Spine & Trauma 3D
모델명 / 제조번호(시리얼번호)
Brainlab Navigation System Spine & Trauma 3DSerial Numbers: XXXXXXXX-19154-03 and XXXXXXXX-19154-04ARTG Number 96517
의료기기 분류등급
Neurological Devices
AIRO Mobile CT Scanner Model: MobiCT-32
모델명 / 제조번호(시리얼번호)
AIRO Mobile CT Scanner Model: MobiCT-32Serial Numbers: AIRO-0162, AIRO-0143, AIRO-0154, AIRO-0146, AIRO-0149, AIRO-0209 and AIRO-0217 ARTG Number: 223542
의료기기 분류등급
Radiology Devices
AIRO Mobile CT ScannerModel Number: MobiCT-32
모델명 / 제조번호(시리얼번호)
AIRO Mobile CT ScannerModel Number: MobiCT-32Catalogue Number: 2017-FSCA-001Serial Numbers: AIRO-0162, AIRO-0143, AIRO-0154, AIRO-0146 and AIRO-0149ARTG Number: 223542
Brainlab Offset Cup Impactor Universal (blue handle)
모델명 / 제조번호(시리얼번호)
Brainlab Offset Cup Impactor Universal (blue handle)Catalogue Numbers: 52856, 52856AARTG Number: 121094
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여기
Brainlab Australia Pty Ltd
제조사 모회사 (2017)
Brainlab AG
Source
RLMPH
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