Recall Z-1082-2019 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
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.
| Date | Apr 15, 2019 (initiated Feb 27, 2019) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | The 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 r |
| Quantity | 148 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070106 | VV FLUORO 3D Brainlab AG, Apr 23, 2007 |