Brainlab AG recalls BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Sp

Recalled November 25, 2015 · FDA recall Z-0282-2016 · Brainlab AG

Hazard

Instances of data sets not being accurately registered to the patient anatomy were observed. · FDA Class II

Units

12 systems total (10 in U.S., 2 in Australia)

Sold at

Distributed in the US and Australia.

Description

Instances of data sets not being accurately registered to the patient anatomy were observed.

Product

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(s)

Brainlab AG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →