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.
Check against the official notice below — it lists the full affected range.
Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software (Version 1.0.0.249) used during spine surgery to help surgeons navigate surgical instruments. The software can unexpectedly display the surgical instrument's position in an incorrect view format with fixed image planes instead of the standard view typically used for instrument navigation. When this occurs, the surgeon may be unable to accurately determine where the surgical instrument is positioned. This problem can happen after the software recovers from a crash or when switching between different navigation workflows during the same patient procedure. The recall affects 148 units distributed worldwide in the United States and 24 other countries including Canada, the United Kingdom, Japan, Australia, and others.
The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: 148 units Lot/code info: Version 1.0.0.249, GTIN 04056481140328
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.