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.
Published April 24, 2019 · Recall initiated: February 27, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Brainlab AG
- Distributor
- 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.
- Lot
- Version 1.0.0.249, GTIN 04056481140328
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- Germany
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.