Company: Brainlab AG
Date of Enforcement Report 11/25/2015
Class lI:

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.
Recall Number Z-0282-2016

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

RECALLING FIRM/MANUFACTURER
Brainlab AG Feldkirchen, DE on 5/8/2015 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12 systems total (10 in U.S., 2 in Australia)

DISTRIBUTION
US and Australia

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