Devices

Device Recall BrainLAB Image Guided Surgery (IGS) System VectorVision fluoro 3D

Model / Serial
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)
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the US and Australia.
Product Description
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
Brainlab AG
1 Event
- Recall of Device Recall BrainLAB Image Guided Surgery (IGS) System VectorVision fluoro 3D

Manufacturer

Brainlab AG

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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