Recall Z-0598-2016 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
| Date | Jan 19, 2016 (initiated Apr 22, 2013) |
| Status | Terminated |
| Reason | Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy. |
| Root cause | Software in the Use Environment |
| Action | The firm, Brainlab AG, sent out a "Field Safety Notice / Product Notification" CAPA-20130417-000315 Brainlab Cranial Navigation System: Effect of setup on overall navigation accuracy for all versions of software on 4/22/2013 and an update on 5/29/2015. - From April 22, 2013 has been distributed via email to the consignees. - UPDATE from May 29, 2015 was distributed via email to the medical users. An active reply by the consignees will be followed, if necessary via further different communication media. FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter describes the product, problem and acti |
| Quantity | 2528 units / 2119 consignees |
| Distribution | Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092467 | VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED Brainlab AG, May 6, 2010 |