Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is recall: Software Issue
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive…
Why was Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is recalled?
Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the gantry position of the scanner. The gantry position can either be entered manually or submitted automatically from the CT scanner. If automatic gantry communication is available, the so-called "
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: 19061-03
- Product
- Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive…
- Recalling firm
- Brainlab AG
- Quantity
- 17 systems
- Distribution
- Worldwide distribution: US (nationwide) including states of: NC, NY, OH, WI;and countries of: Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia.
- Recall date
- August 20, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)