FDA Device recall Z-1469-2014
Brainlab, Spine & Trauma 3D 2.0, Navigation Software
- FDA Device
- Class II
- terminated
- Published 2014-04-23
On 2014-04-23 the FDA classified a Class II recall of Brainlab, Spine & Trauma 3D 2.0, Navigation Software by Brainlab Ag, citing 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 anato….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1469-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-18 |
| Published | 2014-04-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Brainlab Ag |
| Distribution | AZ, CA, GA, IL, IN, LA, MA, MI, NC, NY, OH, PA, TN, TX, WI |
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
Identifiers
| code_info | Catalog Number: 22264; Serial Numbers: 000000000038012001 , 000000000060912001 , 000000000189912001 , 00000000022491…Catalog Number: 22264; Serial Numbers: 000000000038012001 , 000000000060912001 , 000000000189912001 , 000000000224912001 , 000000000235512001 , 000000000282912001 , 000000000313612001 , 000000000319412001 , 000000000351112001 , 000000000356912001 , 000000000367212001 , 000000000433712001 , 000000000482012001 , 000000000502812001 , 000000000645612001 , 000000000731112001 , 000000000837312001 , 000000000898312001 , 000000000956812001 , 000000000998412001 , 000000001012812001 , 000000001105412001 , 000000001231812001 , 000000001353512001 , 000000001355412001 , 000000001433712001 , 000000001473712001 , 000000001493512001 , 000000001493712001 , 000000001566212001 , 000000001579112001 , 000000001635112001 , 000000001758212001 , 000000001770212001 , 000000001789312001 , 000000001868312001 , 000000001895412001 , 000000001909912001 , 000000002036112001 , 000000002309812001 , 000000002439112001 , 000000002468312001 , 000000002503012001 , 000000002573012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1469-2014%22
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