25
Nov
2015

BrainLAB Image Guided Surgery Cl II

0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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