Z-1082-2019Class I

Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 )...

Name: Z-1082-2019 Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 )...
Creator: Brainlab AG
Published: 2019-02-27
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2019-02-27 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System... on 2019-02-27. FDA classified it as Class I and gives the reason as "In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1082-2019
Classification: Class I
Status: Terminated
Initiated: 2019-02-27
Posted: 2019-04-15
Terminated: 2019-07-10
Recalling firm: Brainlab, Inc.
Product: Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
Root cause tag: software
FDA root cause: Software design
Action: The firm, BrainLab, notified their existing customer base by email on with a letter entitled "URGENT FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" 02/25/2019. The notice explained the issue, product and actions to be taken. The customers were instructed to do the following: "User Corrective Action: 1. Avoid workflow changes with already registered datasets, if possible. If not absolutely necessary (e.g., for intraoperative screw planning), avoid switching between the workflow application selections 3D Navigation Intraoperative Imaging and 3D Navigation during one patient treatment. 2. After restarting the application with a previously registered dataset (crash restore or workflow change), always activate and deactivate the sub-menu Orientation once to ensure that the correct, expected view representations are displayed for the current session. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning in the Brainlab Spine & Trauma 3D Navigation 1.0 Software User Guide: Before beginning any surgical step, always ensure that navigation accuracy can be sufficiently maintained. If a surgical step could easily lead to reference displacement, remount the reference at an optimal position with a reduced possibility of displacement, and then register and verify again. The following methods can be used to ensure accuracy is sufficient: - Landmark verification - Fluoroscopy (compare the instrument location in the fluoro image with the display on the navigation system)" Brainlab will provide all affected customers with a software revision of Spine & Trauma Navigation Software with the described issue corrected. Brainlab will actively contact you, starting in June 2019 to schedule the update. If you have any questions, contact the Customer Hotline: +49 89 99 15 68 1044 or +1 800 597 5911 (for US customers)
Quantity in commerce: 148 units
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Kazakhstan, Malaysia, New Zealand, Philippines, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand and United Kingdom.
Product codes and lots: Version 1.0.0.249, GTIN 04056481140328

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1082-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1082-2019	Class I	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)