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.
Enforcement
- Recall Number
- Z-1082-2019
- Event ID
- 82304
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Brainlab AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 24, 2019
- Initiation Date
- February 27, 2019
- Classification Date
- April 15, 2019
- Termination Date
- July 10, 2019
- Address
- Olof-palme-str. 9, N/A, Munich, N/A, N/A, Germany
Description
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.
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.
Version 1.0.0.249, GTIN 04056481140328
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.
148 units