Brainlab AG: Medical Device Recall in 2015 - (Recall #: Z-0282-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 8, 2015

Date Posted: November 25, 2015

Recall Number: Z-0282-2016

Event ID: 71248

Reason for Recall:

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

Status: Terminated

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

Code Information:

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)

Distribution Pattern:

Distributed in the US and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated