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.

Detalles del retiro

Fabricante

Brainlab AG

Distribuidor

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.

Lote

1) Model 22035 , VVC NAVIGATION SOFTWARE CRANIAL 5.0 , Serial Numbers: 22035-103911-004 , 22035-103953-001 , 22035-103977-001 , 22035-103982-002 , 22035-103987-001 , 22035-103988-001 , 22035-104566-001 ; 2) Model 22040 , VV NAVIGATION SOFTWARE CRANIAL 4.0 , Serial Numbers: 22040/18820 , 22040/21370 , 22040/26909 , 22040/36997 , 22040-103675-006 , 22040-103687-009 , 22040-103710-001 , 22040-103942-008 , 22040-103974-011 , 22040-104067-001 , 22040-104072-001 , 22040-104114-001 , 22040-104148-001 , 22040-104151-001 , 22040-104505-001 , 22040-104542-001 , 22040-104545-001 , 22040-104614-005 , 22040-123772-001 ; 3) Model 22040-02 , VV NAV SW CRANIAL 7.8.1 (ANY PLATFORM) , Serial Number: 000000002600509001 ; 4) Model 22040-11 , UPDATE VV NAV SW CRANIAL 7.9.1 FROM 7.9 , Serial Numbers: 000000007665811001 , 000000007801111004 , 000000007801111005 , 000000007801111006 , 000000007801111007 , 000000007801111008 , 000000007801111009 , 000000007808711004 , 000000007808711007 , 000000007808711008 , 000000007837611010 , 000000007847411007 , 000000007865211004 , 000000007865211005 , 000000007942211004 , 000000007942211008 , 000000007942211010 , 000000007950411001 , 000000007950411004 , 000000007950411007 , 000000007950411010 , 000000007956611005 , 000000007956611010 , 000000007956611017 , 000000007965011001 , 000000007965011006 , 000000007965011007 , 000000007980111001 , 000000007980111002 , 000000007980111003 , 000000007980111004 , 000000007980111005 , 000000007980111006 , 000000007980111007 , 000000008000111003 , 000000008000111006 , 000000008000111007 , 000000008012411001 , 000000008012411003 , 000000008012411008 , 000000008026011002 , 000000008026011003 , 000000008036811002 , 000000008036811006 , 000000008036811007 , 000000008036811008 , 000000008036911002 , 000000008036911004 , 000000008036911005 , 000000008046111002 , 000000008046111005 , 000000008073511003 , 000000008073511007 , 000000008086811001 , 000000008106711001 , 000000008114111004 , 000000008129711004 , 000000008129711005 , 000000008129711006 , 000000008133311001 , 000000008133311002 , 000000008143111002 , 000000008143111003 , 000000008143111004 , 000000008157411005 , 000000008157411007 , 000000008167811005 , 000000008167811008 , 000000008167811012 , 000000008167811014 , 000000008167811015 , 000000008167811016 , 000000008180811001 , 000000008180811008 , 000000008180811009 , 000000008180811010 , 000000008180811011 , 000000008181011002 , 000000008208411002 , 000000008230111001 , 000000008230111002 , 000000008230111009 , 000000008230111013 , 000000008230111015 , 000000008230111022 , 000000008230111024 , 000000008230111025 , 000000008230211001 , 000000008230211002 , 000000008230211008 , 000000008230211017 , 000000008230211020 , 000000008230211025 , 000000008230211030 , 000000008230311006 , 000000008230311014 , 000000008230311015 , 000000008230311018 , 000000008230411003 , 000000008230411005 , 000000008230411009 , 000000008230411010 , 000000008230411012 , 000000008230411016 , 000000008230411021 , 000000008230411024 , 000000008230411029 , 000000008230411030 , 000000008230411031 , 000000008230411032 , 000000008242111002 , 000000008242111003 , 000000008242111005 , 000000008242611001 , 000000008242611002 , 000000009168012001 ; 5) Model 22040B , VV NAVIGATION SOFTWARE CRANIAL7.5.0 , Serial Numbers: 05-48916-22040B , 05-51803-22040B , 05-52149-22040B , 22040B/46911 ; 6) Model 22040C , VV NAVIGATION SOFTWARE CRANIAL 7.6.0 , Serial Numbers: 05-63659-22040C , 05-63669-22040C , 05-66754-22040C , 06-79914-22040C ; 7) Model 22040D , VV NAVIGATION SW CRANIAL 7.7 , Serial Numbers: 06-84302-22040D , 06-85635-22040D , 06-88801-22040D ; 8) Model 22040E , VV NAVIGATION SW CRANIAL 7.8 , Serial Numbers: 06-101594-22040E , 06-103819-22040E , 06-108132-22040E , 07-102189-22040E , 07-106354-22040E , 07-108464-22040E , 07-109071-

Clasificación de riesgo

Class I

Área (FDA)

device

País

Germany