Z-0282-2016Class II

BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version...

Name: Z-0282-2016 BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version...
Creator: Brainlab AG
Published: 2015-05-08
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2015-05-08 / Terminated / root cause: manufacturing process

FDA source

Brainlab AG began a recall of 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... on 2015-05-08. FDA classified it as Class II and gives the reason as "Instances of data sets not being accurately registered to the patient anatomy were observed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0282-2016
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Posted: 2015-11-17
Terminated: 2017-02-28
Recalling firm: Brainlab, Inc.
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Instances of data sets not being accurately registered to the patient anatomy were observed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated April 30, 2015 was sent to all direct accounts (customers). The letters included instructions for customers to: To reduce the risk of an inappropriate automatic registration, Brainlab, in cooperation with NeuroLogica, has developed an improved integration- and verification-workflow to be followed, and additionally wants to re-iterate important use instructions, as described below and specified in detail in the Appendix of this document. When using Brainlab's navigation software to perform automatic registration of CT image data sets in combination with NeuroLogica BodyTom, please ensure that the following conditions are always fulfilled: 1) Ensure suitability of OR Ensure that the operating room where the BodyTom is used in combination with the Brainlab navigation has a continuously even floor. The flatness must not exceed 1mm (0.04 in) for 1m (39.4 in). Please take into account that the flatness may change over time due to wear of the floor coating material and/or negative impacts under the load of equipment used in the room. Ensure that the OR still fulfills the initial specifications before use. 2) Ensure a valid calibration of the BodyTom Automatic registration with the BodyTom may only be used if a valid calibration and verification of the BodyToms mechanical position is given. Both BodyTom and Brainlab calibration must be performed on the same position and movement path that is used for the navigated clinical procedure. The use of Brainlab navigation system is restricted to the one room and movement path where the calibration has been performed. If multiple calibrated rooms are listed on the BodyTom, please ensure that the correct room is selected on the BodyTom workstation when preparing the scan. As part of the Brainlab Corrective Action (see below) you will be contacted by a Brainlab employee to assist in the selection and marking of a suitable movement path and to perform th
Quantity in commerce: 12 systems total (10 in U.S., 2 in Australia)
Distribution: Distributed in the US and Australia.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0282-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0282-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-17

Product code HAW

K070106Class IIVv Fluoro 3DBrainlab AG / cleared 2007-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)