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U.S. Department of Health and Human Services

Class 1 Device Recall Spine & Trauma 3D Navigation 1.0

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 Class 1 Device Recall Spine & Trauma 3D Navigation 1.0see related information
Date Initiated by FirmFebruary 27, 2019
Date PostedApril 15, 2019
Recall Status1 Terminated 3 on July 10, 2019
Recall NumberZ-1082-2019
Recall Event ID 82304
510(K)NumberK070106 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductSpine & 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.
Code Information Version 1.0.0.249, GTIN 04056481140328
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe 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 Commerce148 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HAW
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