Recall Z-1469-2014— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2013-11-18, terminated 2017-07-17. It names one FDA 510(k) clearance: K070106. Product: Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264. Reason: The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated.
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-18
- Terminated
- 2017-07-17
- Firm location
- Feldkirchen, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Reason for recall
The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated
Data sourced from openFDA. This site is unofficial and independent of the FDA.