FDA-Device2015-11-25Class II
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.
Brainlab AG
Hazard
Instances of data sets not being accurately registered to the patient anatomy were observed.
Sold states
Distributed in the US and Australia.
Affected count
12 systems total (10 in U.S., 2 in Australia)
Manufactured in
Kapellenstrasse 12, N/A, Feldkirchen, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2016Don't want to check this manually?
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