BrainLAB Image Guided Surgery (IGS) System, Stereotaxic… recallZ-0282-2016 · Brainlab AG · initiated May 8, 2015
Class II Terminated All recalls posted in November 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Brainlab AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Instances of data sets not being accurately registered to the patient anatomy were observed.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-0282-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 8, 2015
- Posted by the FDA
- Nov 17, 2015
- Recalling firm
- Brainlab AG
- Quantity
- 12 systems total (10 in U.S., 2 in Australia)
- Product code
- HAW
- FDA submissions
- K070106
- Distribution
- Distributed in the US and Australia.
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.
Code information (models, lots, serial numbers)
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)
Other devices under the same FDA submission
1 device cleared under K070106 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Navigation Software Spine & Trauma 3D 2.5Brainlab SE · Neurological Stereotaxic Instrument5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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