Recall Z-1469-2014 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
| Date | Apr 17, 2014 (initiated Nov 18, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter included instructions for the modification of C-arm configurations: 1) If possible, Use analog image transfer between C-arm and Brainlab Navigation System and to consult with the local Brainlab Customer Support Representative for this modification, and 2) If possible, adjust the image size of the C-arm to 8 bit and to follow the instructions provided with the C-arm and i |
| Quantity | 133 units |
| Distribution | 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 F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070106 | VV FLUORO 3D Brainlab AG, Apr 23, 2007 |