Recall record at a glance
| Official record | Z-1469-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Brainlab AG |
| Report date | Apr 23, 2014 |
| Recall initiation date | Nov 18, 2013 |
| Quantity | 133 units |
| Location | Feldkirchen, N/A, Germany |
Official product description
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Why the product 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
Distribution information
Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, France, Germany, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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