Brainlab AG: 20 recalls on record

Recalls filed with 1 agency: FDA (20).

First recall on record: September 4, 2013. Most recent: October 14, 2020.

Risk classification: Class I: 2 · Class II: 18

Most recent recalls

DateAgencyProduct
October 14, 2020FDAUltrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Na…Z-0056-2021
April 24, 2019FDASpine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trau…Z-1082-2019
March 21, 2018FDAExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately …Z-1006-2018
February 14, 2018FDAAIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to…Z-0509-2018
January 17, 2018FDABrainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registrati…Z-0320-2018
December 6, 2017FDABRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC …Z-0172-2018
January 18, 2017FDAFemoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surge…Z-0959-2017
June 15, 2016FDAExacTrac Vero is a Patient Positioning System for Radiation therapy.Z-1929-2016
January 27, 2016FDABrainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiol…Z-0598-2016
January 20, 2016FDART Elements are applications for radiation treatment planning for use in stereotactic, co…Z-0648-2016
May 13, 2015FDAExacTrac 6.x. is software used to place patients at an accurately defined point within th…Z-1582-2015
January 21, 2015FDAiPlan RT is a radiation treatment planning system that is intended for use in stereotacti…Z-0957-2015
August 20, 2014FDANavigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative ima…Z-2213-2014
August 13, 2014FDAExacTrac is intended to be used to place patients at an accurately defined point within t…Z-2146-2014
August 6, 2014FDAPatient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) …Z-2134-2014
June 11, 2014FDAExacTrac 5.5, an Image Processing System used for patient positioning for radiation thera…Z-1707-2014
May 7, 2014FDAExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: …Z-1513-2014
April 23, 2014FDABrainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided loc…Z-1469-2014
February 19, 2014FDABrainLAB's VectorVision spine is intended for use as an intraoperative image-guided local…Z-0967-2014
September 4, 2013FDABRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rota…Z-2083-2013

Questions about this company

How many recalls does Brainlab AG have?
Recalert has 20 U.S. recalls on record for Brainlab AG, published between September 4, 2013 and October 14, 2020.
What was the most recent Brainlab AG recall?
FDA recall Z-0056-2021, published October 14, 2020: Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system …
Which agencies have handled Brainlab AG recalls?
Brainlab AG appears as the recalling firm in recalls from: FDA (20).

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