Reported Apr 23, 2014 · Terminated
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable…
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Kapellenstrasse 12 · Feldkirchen, N/A · N/A
Is this the product you have?
- Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery
- Catalog Number22264
- Lot codes and dates
- Catalog Number22264
- Serial Numbers
133 of 133 codes
000000000038012001000000000060912001000000000189912001000000000224912001000000000235512001000000000282912001000000000313612001000000000319412001000000000351112001000000000356912001000000000367212001000000000433712001000000000482012001000000000502812001000000000645612001000000000731112001000000000837312001000000000898312001000000000956812001000000000998412001000000001012812001000000001105412001000000001231812001000000001353512001000000001355412001000000001433712001000000001473712001000000001493512001000000001493712001000000001566212001000000001579112001000000001635112001000000001758212001000000001770212001000000001789312001000000001868312001000000001895412001000000001909912001000000002036112001000000002309812001000000002439112001000000002468312001000000002503012001000000002573012001000000002682913001000000003000913001000000003053313001000000003066813001000000003071613001000000003087613001000000003109513001000000003109613001000000003230113001000000003246713001000000003304113001000000003331913001000000003379313001000000003453413001000000003453513001000000003622213001
- Amount recalled
- 133 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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