Z-1082-2019 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- February 27, 2019
- Termination Date
- July 10, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148 units
Product 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.
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.
Distribution Pattern
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.
Code Information
Version 1.0.0.249, GTIN 04056481140328