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Brainlab AG recalls Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLA
Recalled January 27, 2016 · FDA recall Z-0598-2016 · Brainlab AG
Hazard
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. · FDA Class I
Units
2528 units / 2119 consignees
Sold at
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, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
Description
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.
Product
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.
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →