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

FDA Device Recall #Z-0282-2016 — Class II — May 8, 2015

Recall Summary

Recall Number Z-0282-2016
Classification Class II — Moderate risk
Date Initiated May 8, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Brainlab AG
Location Feldkirchen, N/A
Product Type Devices
Quantity 12 systems total (10 in U.S., 2 in 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.

Reason for Recall

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

Distribution Pattern

Distributed in the US and Australia.

Lot / 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)

Other Recalls from Brainlab AG

Recall # Classification Product Date
Z-1392-2025 Class II Origin Data Management software versions 3.1.0,... Feb 10, 2025
Z-1292-2023 Class II Cirq Arm System 2.0 Mar 2, 2023
Z-1259-2023 Class II Brainlab ExacTrac Dynamic software, Medical Cha... Feb 14, 2023
Z-0733-2022 Class II ExacTrac Dynamic software model numbers: 209... Feb 25, 2022
Z-1846-2021 Class II ExacTrac Dynamic software, Model 20910-01B ETD ... May 14, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.