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U.S. Department of Health and Human Services

Class 1 Device Recall Brainlab Cranial Navigation System

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  Class 1 Device Recall Brainlab Cranial Navigation System see related information
Date Initiated by Firm April 22, 2013
Date Posted January 19, 2016
Recall Status1 Terminated 3 on April 17, 2018
Recall Number Z-0598-2016
Recall Event ID 71924
510(K)Number K092467  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
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.
Code Information 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 , 07-109071-22040E , 07-109217-22040E , 07-110114-22040E , 07-112255-22040E , 07-112347-22040E , 07-113858-22040E , 07-114331-22040E , 07-117343-22040E , 07-118687-22040E , 07-118695-22040E , 07-119019-22040E , 07-119599-22040E , 07-120231-22040E , 07-120842-22040E , 07-122228-22040E , 07-123321-22040E , 07-124014-22040E , 07-126723-22040E , 07-128644-22040E , 07-129197-22040E , 07-129354-22040E , 07-130356-22040E ;  9) Model 22040F , VV NAVIGATION SW CRANIAL 7.8.1 , Serial Numbers:  000000001242908001 , 000000001275408001 , 000000001305408001 , 000000001346908001 , 000000001386608001 , 000000001402808001 , 000000001506308001 , 000000001516208001 , 000000001548508001 , 000000001611208001 , 000000001644608001 , 000000001716308001 , 000000001730608001 , 000000001832508001 , 000000001832608001 , 000000001867508001 , 000000001869408001 , 000000001924908001 , 000000001943208001 , 000000001944708001 , 000000002054708001 , 000000002082108001 , 000000002179709001 , 000000002352209001 , 000000002401209001 , 000000002540709001 , 000000002540809001 , 000000002565609001 , 000000002565809001 , 000000002610309001 , 000000002921409001 , 000000002945709001 , 000000003057109001 , 000000003171909001 , 000000003331709001 , 000000003433809001 , 000000003446909001 , 3540908001 , 3557608001 , 6039008001 , 6110908001 , 6303008001 , 6406408001 , 6594408001 , 6655308001 , 6757308001 , 6983608001 , 07-133796-22040F , 07-134724-22040F , 07-135062-22040F , 07-135413-22040F , 07-136068-22040F , 07-136871-22040F , 07-137864-22040F , 07-138500-22040F , 07-138954-22040F , 07-138987-22040F , 07-139009-22040F , 07-139027-22040F , 07-139037-22040F , 07-139083-22040F , 07-139412-22040F , 07-139955-22040F , 07-141837-22040F , 07-144111-22040F , 07-145211-22040F , 07-146009-22040F , 08-148434-22040F , 08-149705-22040F , 08-153066-22040F , 08-154083-22040F , 08-155770-22040F , 08-156023-22040F , 08-156226-22040F , 08-156570-22040F , 08-157148-22040F , 08-157972-22040F ;  10) Model 22040H , VV NAVIGATION SW CRANIAL 7.9.1 , Serial Numbers:  000000004274913001 , 000000008413811001 ;  11) Model 22043 , UPDATE VV NAV SWCRANIAL 6.0 TO 6.01 , Serial Numbers:  07-135238-22043 , 22043/1194 ;  12) Model 22204-02 , KOLIBRI NAV SW CRAN 2.6.1 (ANY PLATFORM) , Serial Number: 000000003102809001 ;  13) Model 22204B , KOLIBRI NAVIGATION SW CRANIAL 2.5.0 , Serial Number: 06-86477-22204B ;  14) Model 22204C , KOLIBRI NAVIGATION SW CRANIAL 2.6.0 , Serial Numbers:  06-100679-22204C , 06-104941-22204C , 07-112890-22204C , 07-114630-22204C , 07-116967-22204C , 07-123214-22204C , 07-128684-22204C , 07-129055-22204C , 07-133191-22204C , 07-133265-22204C , 15) Model 22204D , KOLIBRI NAVIGATION SW CRANIAL 2.6.1 , Serial Numbers:  000000001120208001 , 000000001125508001 , 000000001178108001 , 000000001291308001 , 000000001343608001 , 000000001362808001 , 000000001671208001 , 000000002019108001 , 000000002108909001 , 000000002219709001 , 000000002308509001 , 000000002494309001 , 6259008001 , 6381208001 , 6662908001 , 6898208001 , 07-134523-22204D , 07-135013-22204D , 07-135592-22204D , 07-141778-22204D , 07-142020-22204D , 07-149290-22204D , 08-148598-22204D , 08-152171-22204D , 08-153392-22204D , 08-153694-22204D , 08-154014-22204D , 08-154473-22204D , 08-157303-22204D , 08-157669-22204D ;  16) Model 22204E , KOLIBRI NAVIGATION SW CRANIAL 2.7 , Serial Number: 000000003211909001 ;  17) Model 22207 , CRANIAL ESSENTIAL NAV SW 1.0 , Serial Numbers: 000000002787409001 ,  000000002796409001 , 000000002811509001 , 000000002867009001 , 000000002906409001 , 000000002930409001 , 000000003058009001 , 000000003220409001 , 000000003224109001 , 000000003546309001 , 000000003576409001 , 000000003680909001 , 000000003738509001 , 000000003982409001 , 000000003990809001 , 000000004154809001 , 000000004494710001 , 000000004535510001 , 000000004622210001 , 000000004636910001 , 000000004804710001 , 000000004910010001 , 000000004923210001 , 000000005074410001 , 000000005078110001 , 000000005100710001 , 000000005153810001 , 000000005353810001 , 000000005354110001 , 000000005427710001 , 000000005453410001 , 000000005607210001 , 000000005651510001 , 000000005668710001 , 000000005710010001 , 000000005736910001 , 000000005838110001 , 000000006077510001 , 000000006148710001 , 000000006179010001 , 000000006306910001 , 000000006339910001 , 000000006363010001 , 000000006726411001 , 000000006949311001 , 000000007053911001 , 000000007076211001 , 000000007146511001 , 000000007172711001 , 000000007302311001 , 000000007418911001 ;  18) Model 22207A , CRANIAL ESSENTIAL NAVIGATION SW 1.0.1 , Serial Number: 000000007678411001 ;  19) Model 22208 , CRANIAL UNLIMITED NAV SW 1.0 , Serial Numbers: 000000002958709001 , 000000003668009001 , 000000004574810001 , 000000004694310001 , 000000005096210001 , 000000005278010001 , 000000005728710001 , 000000006119610002 , 000000006119610003 , 000000006119610004 , 000000006119610005 , 000000006271410001 , 000000006654910001 , 000000006694611001 , 000000006786911001 ;  20) Model 22208-11 , UPDATE CRANIAL UNLIMITED 1.0.1 FROM 1.0 , Serial Numbers: 000000007719311001 , 000000007757911001 , 000000007775111001 , 000000007801311002 , 000000007801311005 , 000000007808811004 , 000000007814811001 , 000000007814811002 , 000000007830611001 , 000000007830611003 , 000000007837811001 , 000000007837811003 , 000000007837811004 , 000000007847611002 , 000000007856311001 , 000000007856311003 , 000000007856311005 , 000000007856311006 , 000000007865011004 , 000000007865011005 , 000000007865011006 , 000000007891211001 , 000000007891211002 , 000000007891211003 , 000000007891211004 , 000000007891211005 , 000000007927911001 , 000000007927911002 , 000000007927911003 , 000000007927911005 , 000000007927911009 , 000000007928011001 , 000000007928011002 , 000000007928011003 , 000000007942511002 , 000000007942511003 , 000000007942511005 , 000000007942511006 , 000000007942511013 , 000000007942511014 , 000000007942511016 , 000000007942511018 , 000000007950711002 , 000000007950711004 , 000000007950711005 , 000000007950711009 , 000000007950711011 , 000000007957111012 , 000000007980311001 , 000000007980311002 , 000000007980311004 , 000000007980311006 , 000000007980311010 , 000000007980311011 , 000000007980311012 , 000000008012711002 , 000000008012711004 , 000000008025711001 , 000000008025711002 , 000000008025711003 , 000000008037311001 , 000000008037411001 , 000000008037411002 , 000000008037411003 , 000000008037411005 , 000000008045711002 , 000000008045711004 , 000000008059111001 , 000000008059211001 , 000000008074511004 , 000000008074511006 , 000000008074511008 , 000000008074511009 , 000000008074511011 , 000000008074511013 , 000000008074511014 , 000000008074511016 , 000000008074611001 , 000000008074611002 , 000000008087011002 , 000000008087011004 , 000000008087011008 , 000000008087011009 , 000000008087011010 , 000000008087011011 , 000000008087211001 , 000000008106811001 , 000000008106811003 , 000000008106811004 , 000000008114411002 , 000000008114411005 , 000000008114411009 , 000000008114411012 , 000000008129911003 , 000000008129911004 , 000000008129911005 , 000000008129911006 , 000000008129911007 , 000000008129911008 , 000000008134911002 , 000000008134911003 , 000000008134911004 , 000000008134911005 , 000000008134911006 , 000000008134911007 , 000000008134911008 , 000000008134911009 , 000000008134911010 , 000000008134911011 , 000000008134911016 , 000000008143611001 , 000000008143611002 , 000000008143611004 , 000000008143611006 , 000000008143611007 , 000000008143611008 , 000000008143611010 , 000000008143611011 , 000000008143611012 , 000000008143611016 , 000000008143611018 , 000000008143611019 , 000000008143611020 , 000000008143611024 , 000000008143611026 , 000000008143611027 , 000000008150011001 , 000000008150011003 , 000000008150011004 , 000000008150011005 , 000000008150011006 , 000000008157811001 , 000000008157811002 , 000000008157811003 , 000000008157811007 , 000000008157811008 , 000000008157811009 , 000000008157811010 , 000000008157811012 , 000000008168311002 , 000000008168311005 , 000000008168311006 , 000000008168311007 , 000000008168311008 , 000000008168311009 , 000000008168311010 , 000000008168311011 , 000000008181511003 , 000000008181511004 , 000000008208911001 , 000000008208911004 , 000000008208911005 , 000000008222511001 , 000000008222511002 , 000000008222511003 , 000000008222511005 , 000000008222511006 , 000000008222511008 , 000000008222511009 , 000000008222511010 , 000000008222511011 , 000000008222511013 , 000000008222511014 , 000000008230711001 , 000000008230711004 , 000000008230711005 , 000000008230711006 , 000000008230711007 , 000000008230711008 , 000000008242711001 , 000000008242711005 , 000000008242711006 , 000000008242711008 , 000000008242711009 , 000000008242711010 , 000000008242711011 , 000000008242711012 , 000000008242711013 , 000000008242711015 , 000000008242711016 , 000000008242711019 , 000000008242711020 , 000000008242711023 , 000000008242711024 , 000000008242711025 , 000000008242711026 , 000000008242711027 , 000000008242711028 , 000000008242711029 , 000000008242711031 , 000000008242711033 , 000000008242711034 , 000000008242711035 , 000000008242711036 , 000000008242711038 , 000000008242711041 , 000000008242711042 , 000000008242711043 , 000000008242711044 , 000000008277511001 , 000000008352911001 , 000000009167712001 , 000000009167812001 , 000000009167912001 , 000000009239412001 , 000000009359612001 , 000000009408712001 , 000000009408812001 ;  21) Model 22208A , CRANIAL UNL NAVIGATION SW 1.0.1 , Serial Numbers: 000000001287412001 , 000000003539513001 , 000000004457713001 , 000000008293111001 , 000000008471411001 , 000000008489611001 ;  22) Model 22214 , CRANIAL NAVIGATION SW 2.1 , Serial Numbers: 000000007467211001 , 000000007489111001 , 000000007494611001 , 000000007495311001 , 000000007505911001 , 000000007516811001 , 000000007516911001 , 000000007545411001 , 000000007572811001 , 000000007576811001 , 000000007578311001 , 000000007604811001 , 000000007605711001 , 000000007605811001 , 000000007605911001 , 000000007683111001 , 000000007695511001 , 000000007735211001 , 000000007773611001 , 000000007777511001 , 000000007802011001 , 000000007840911001 , 000000007872611001 , 000000007899411001 , 000000007936111001 , 000000007954111001 , 000000007960411001 , 000000007973911001 , 000000008063011001 , 000000008067111001 , 000000008100511001 , 000000008111511001 , 000000008165111001 , 000000008189511001 , 000000008210511001 , 000000008245011001 , 000000008245111001 , 000000008260011001 , 000000008290111001 , 000000008370011001 , 000000008431811001 , 000000008441811001 ;  23) Model 22214-01 , UPDATE CRANIAL 2.1.1 FROM 2.1 , Serial Numbers: 000000008574211001 , 000000008741911001 , 000000008861011001 , 000000008980412001 , 000000009122512001 , 000000009199812001 , 000000009237012001 , 000000009283712001 , 000000009283812001 , 000000009283912001 , 000000009284012001 , 000000009284112001 , 000000009316312001 , 000000009363312001 , 000000009422712001 , 000000009437312001 , 000000009437412001 , 000000009437512001 , 000000009437612001 , 000000009481412001 , 000000009861512001 ;  24) Model 22214-01A , UPD CRANIAL 2.1.1 W/ DATA LOAD FROM 2.1 , Serial Numbers: 000000000239512001 , 000000000246112001 , 000000000605512001 , 000000000605814001 , 000000000797312001 , 000000000815712001 , 000000001221412001 , 000000001866612001 , 000000001866712001 , 000000002099012001 , 000000002698513001 , 000000004417413001 , 000000009530014001 ;  25) Model 22214-01B , UPD CRANIAL 2.1.1 W/ DATA LOAD FROM 2.1 , Serial Numbers: 000000000051714001 , 000000005104313001 , 000000006146515001 , 000000006146615001 , 000000006146715001 , 000000006146815001 , 000000007622015001 , 000000009289414001 ;  26) Model 22214A , CRANIAL NAVIGATION SW 2.1.1 , Serial Numbers: 000000000052612001 , 000000000052712001 , 000000000055912001 , 000000000157012001 , 000000008553411001 , 000000008598111001 , 000000008615711001 , 000000008624811001 , 000000008674211001 , 000000008700211001 , 000000008714811001 , 000000008715911001 , 000000008766711001 , 000000008795711001 , 000000008844011001 , 000000008848411001 , 000000008861911001 , 000000008874011001 , 000000008902511001 , 000000008947212001 , 000000008968312001 , 000000009013812001 , 000000009022712001 , 000000009043912001 , 000000009053712001 , 000000009106912001 , 000000009133112001 , 000000009133612001 , 000000009134012001 , 000000009168512001 , 000000009306012001 , 000000009342012001 , 000000009382912001 , 000000009395512001 , 000000009401412001 , 000000009461012001 , 000000009505812001 , 000000009551212001 , 000000009559212001 , 000000009573412001 , 000000009647912001 , 000000009654412001 , 000000009654612001 , 000000009745412001 , 000000009763112001 , 000000009787112001 , 000000009788212001 , 000000009816112001 , 000000009816212001 , 000000009819512001 , 000000009867212001 , 000000009885512001 , 000000009926512001 , 000000009944112001 , 000000009951112001 , 000000009964612001 ;  27) Model 22214B , CRANIAL NAVIGATION SW 2.1.1 , Serial Numbers: 000000000240112001 , 000000000240212001 , 000000000254712001 , 000000000353512001 , 000000000385712001 , 000000000385812001 , 000000000405512001 , 000000000406612001 , 000000000496312001 , 000000000503212001 , 000000000520312001 , 000000000546512001 , 000000000574812001 , 000000000587912001 , 000000000615712001 , 000000000623212001 , 000000000681112001 , 000000000709312001 , 000000000709412001 , 000000000712112001 , 000000000725312001 , 000000000726312001 , 000000000760512001 , 000000000792812001 , 000000000813012001 , 000000000848912001 , 000000000871612001 , 000000000959612001 , 000000001014212001 , 000000001132612001 , 000000001168512001 , 000000001196612001 , 000000001213712001 , 000000001235712001 , 000000001324112001 , 000000001341012001 , 000000001354912001 , 000000001362412001 , 000000001382112001 , 000000001384512001 , 000000001634612001 , 000000001634712001 , 000000001635012001 , 000000001645912001 , 000000001695412001 , 000000001705512001 , 000000001752412001 , 000000001782812001 , 000000001783612001 , 000000001804712001 , 000000001823412001 , 000000001850912001 , 000000001873512001 , 000000001882512001 , 000000001936612001 , 000000001938712001 , 000000001938812001 , 000000002045412001 , 000000002059512001 , 000000002104112001 , 000000002179412001 , 000000002240312001 , 000000002323212001 , 000000002346312001 , 000000002360212001 , 000000002368012001 , 000000002370912001 , 000000002371012001 , 000000002380812001 , 000000002401612001 , 000000002421712001 , 000000002422812001 , 000000002424312001 , 000000002433512001 , 000000002444812001 , 000000002508012001 , 000000002580412001 , 000000002610013001 , 000000002615112001 , 000000002662913001 , 000000002682613001 , 000000002705213001 , 000000002714613001 , 000000002788513001 , 000000002815713001 , 000000002967013001 , 000000002988213001 , 000000003009213001 , 000000003053413001 , 000000003059013001 , 000000003067613001 , 000000003071813001 , 000000003158813001 , 000000003223813001 , 000000003273213001 , 000000003286913001 , 000000003297813001 , 000000003300613001 , 000000003302213001 , 000000003332213001 , 000000003356613001 , 000000003379513001 , 000000003382713001 , 000000003409613001 , 000000003465613001 , 000000003489313001 , 000000003633013001 , 000000003633113001 , 000000003643713001 ;  28) Model 22214C , CRANIAL NAVIGATION SW 2.1 , Serial Numbers: 000000000034814001 , 000000000034914001 , 000000000059214001 , 000000000266114001 , 000000001118214001 , 000000001320614001 , 000000001496814001 , 000000001855614001 , 000000001933214001 , 000000001949014001 , 000000001950314001 , 000000002549514001 , 000000003648014001 , 000000003671614001 , 000000003816414001 , 000000003818813001 , 000000003818913001 , 000000003819013001 , 000000003848013001 , 000000003877714001 , 000000003896213001 , 000000003953413001 , 000000003954013001 , 000000003978813001 , 000000003978913001 , 000000003979013001 , 000000003979113001 , 000000003979213001 , 000000004058613001 , 000000004058713001 , 000000004062414001 , 000000004069313001 , 000000004069413001 , 000000004089813001 , 000000004153413001 , 000000004161613001 , 000000004334713001 , 000000004406013001 , 000000004439913001 , 000000004468913001 , 000000004469013001 , 000000004469113001 , 000000004486313001 , 000000004486413001 , 000000004486513001 , 000000004486613001 , 000000004486713001 , 000000004504313001 , 000000004538314001 , 000000004545113001 , 000000004612413001 , 000000004663813001 , 000000004663913001 , 000000004709113001 , 000000004783814001 , 000000004859613001 , 000000004859713001 , 000000004887513001 , 000000004988313001 , 000000005006513001 , 000000005066313001 , 000000005153913001 , 000000005173713001 , 000000005173813001 , 000000005173913001 , 000000005274015001 , 000000005275513001 , 000000005429413001 , 000000005447613001 , 000000005504713001 , 000000005555513001 , 000000005571213001 , 000000005614113001 , 000000005614213001 , 000000005632713001 , 000000005655613001 , 000000005734813001 , 000000005749813001 , 000000005783213001 , 000000005783313001 , 000000005809913001 , 000000005843413001 , 000000005858813001 , 000000005933613001 , 000000005933713001 , 000000006082113001 , 000000006082213001 , 000000006089613001 , 000000006110313001 , 000000006133613001 , 000000006260615001 , 000000006264013001 , 000000006388913001 , 000000006389013001 , 000000006389113001 , 000000006389213001 , 000000006389313001 , 000000006389413001 , 000000006389513001 , 000000006421115001 , 000000006501613001 , 000000006642913001 , 000000006678013001 , 000000006727313001 , 000000006787613001 , 000000006876713001 , 000000006914715001 , 000000006963413001 , 000000006963513001 , 000000006965115001 , 000000006986013001 , 000000006986113001 , 000000007070313001 , 000000007070413001 , 000000007104213001 , 000000007122413001 , 000000007133613001 , 000000007133713001 , 000000007152313001 , 000000007183813001 , 000000007222213001 , 000000007275913001 , 000000007276013001 , 000000007298113001 , 000000007335813001 , 000000007386913001 , 000000007505713001 , 000000007582914001 , 000000007597214001 , 000000007615214001 , 000000007679014001 , 000000007695914001 , 000000007739514001 , 000000007748814001 , 000000007778815001 , 000000007778915001 , 000000007779015001 , 000000007779115001 , 000000007779215001 , 000000007845614001 , 000000007855114001 , 000000007864215001 , 000000007864315001 , 000000007864415001 , 000000007864515001 , 000000007864615001 , 000000007864715001 , 000000007887514001 , 000000007887614001 , 000000007931114001 , 000000007952814001 , 000000008108414001 , 000000008146114001 , 000000008169214001 , 000000008214914001 , 000000008252814001 , 000000008252914001 , 000000008253014001 , 000000008253114001 , 000000008270014001 , 000000008288414001 , 000000008288514001 , 000000008345715001 , 000000008352914001 , 000000008387414001 , 000000008412014001 , 000000008442114001 , 000000008442214001 , 000000008451814001 , 000000008465514001 , 000000008528214001 , 000000008569214001 , 000000008576714001 , 000000008679414001 , 000000008795114001 , 000000008921914001 , 000000008930314001 , 000000008952114001 , 000000008968714001 , 000000008968814001 , 000000008968914001 , 000000008984714001 , 000000009086514001 , 000000009148214001 , 000000009192514001 , 000000009212114001 , 000000009379914001 , 000000009440114001 , 000000009468614001 , 000000009506614001 , 000000009533714001 , 000000009659414001 , 000000009688014001 , 000000009780614001 , 000000009780714001 , 000000009990514001 , 000000009990614001 ;  29) Model 71000 , VV SOFTWARE UPGRADE CRANIAL 3.X TO 6.01 , Serial Numbers: 71000/21628 , 71000-103744-001 , 71000-103745-002 , 05-49480-71005 ;  30) Model 71006 , UPG VV CRANIAL 6.01 TO CRANIAL 7.0.X , Serial Numbers: 000000002899209001 , 000000003143809001 , 000000004297109001 , 6032908001 , 05-50560-71006 , 05-52155-71006 , 08-148612-71006 ;  31) Model 71008 , UPG VV CRANIAL 7.0 TO CRANIAL 7.5 , Serial Number: 000000004384709001 ;  32) Model 71011 , UPG CRA ESSENTIAL 1.0 TO UNLIMIMITED 1.0 , Serial Numbers: 000000004150309001 , 000000004441110001 ;  33) Model 71011A , UPGRADE CRANIAL ESS 1.0.1 TO UNL 1.0.1 , Serial Numbers: 000000007678511001 , 000000008548411001 ;  34) Model 71012 , UPGRADE VV CRANIAL 7.9 TO UNLIMITED 1.0 , Serial Number: 000000004337709001 ;  35) Model 71012A , UPGRADE VV CRANIAL 7.9.1 TO UNL 1.0.1 , Serial Numbers: 000000005629513001 , 000000005629613001 , 000000005629713001 , 000000005629913001 , 000000005676213001 , 000000005676313001 , 000000005769113001 , 000000005809113001 ;  36) Model 71013 , UPG KOLIBRI CRANIAL 2.7 TO ESSENTIAL 1.0 , Serial Number: 000000002811109001 ;  37) Model 71017 , UPG TO CRAN 2.x FROM CRAN UNLIMITED 1.0 , Serial Numbers: 000000000005412001 ,  000000000060612001 , 000000000108312001 , 000000000108412001 , 000000000108512001 , 000000000251912001 , 000000000316012001 , 000000000388112001 , 000000000721512001 , 000000000722012001 , 000000001002812001 , 000000001015412001 , 000000001114112001 , 000000001114212001 , 000000001279512001 , 000000001291612001 , 000000001311912001 , 000000001336712001 , 000000001358812001 , 000000001511812001 , 000000001652012001 , 000000001757512001 , 000000002034512001 , 000000002777513001 , 000000002788013001 , 000000002911513001 , 000000002958813001 , 000000003056913001 , 000000003067913001 , 000000003094513001 , 000000003151913001 , 000000003187813001 , 000000003242113001 , 000000003538413001 , 000000007545311001 , 000000007587511001 , 000000007678011001 , 000000007725111001 , 000000007888511001 , 000000008050311001 , 000000008084411001 , 000000008231511001 , 000000008264411001 , 000000008283511001 , 000000008377711001 , 000000008444611001 , 000000008529511001 , 000000008579211001 , 000000008579311001 , 000000008579411001 , 000000008676811001 , 000000008676911002 , 000000008855711001 , 000000009001312001 , 000000009002812001 , 000000009079812001 , 000000009146112001 , 000000009162712001 , 000000009168712001 , 000000009187212001 , 000000009208512001 , 000000009411312001 , 000000009470312001 , 000000009470412001 , 000000009484312001 , 000000009599812001 , 000000009632012001 , 000000009652512001 , 000000009760312001 , 000000009840212001 , 000000009931412001 , 000000009931512001 ;  38) Model 71017A , UPG TO CRAN 2.x FROM CRAN UNLIMITED 1.0 , Serial Numbers: 000000001088214001 , 000000002036614001 , 000000002632314001 , 000000002855614001 , 000000003113714001 , 000000003113814001 , 000000003531414001 , 000000003603714001 , 000000003753014001 , 000000003753114001 , 000000003924713001 , 000000003979114001 , 000000004041513001 , 000000004111013001 , 000000004152813001 , 000000004152913001 , 000000004321813001 , 000000004321913001 , 000000004322013001 , 000000004519013001 , 000000004591513001 , 000000004813913001 , 000000004866313001 , 000000004866413001 , 000000005172113001 , 000000005650913001 , 000000006367713001 , 000000006367813001 , 000000006662513001 , 000000006752013001 , 000000006894213001 , 000000006894313001 , 000000006909613001 , 000000007311115001 , 000000007365613001 , 000000007432713001 , 000000007514713001 , 000000007624313001 , 000000007657214001 , 000000007704815001 , 000000007765214001 , 000000008248514001 , 000000008508414001 , 000000009319814001 , 000000009378914001 , 000000009466914001 ;  39) Model 71051 , UPD VV CRANIAL 7.5.X TO 7.6.X , Serial Number: 000000002382609001 ;  40) Model 71053 , UPD VV CRANIAL 7.6.X TO CRANIAL7.7.X , Serial Number: 06-88103-71053 ;  41) Model 71056 , UPD VV CRANIAL 7.7.X TO CRANIAL7.8.X , Serial Numbers: 000000001425108001 , 000000001462008001 , 000000003671509001 , 000000009258012001 ;  42) Model 71063 , UPG KOL CRANIAL 2.5.X TO CRANIAL 2.6.X , Serial Number: 07-111143-71063 ;  43) Model 71067 , UPDATE VV NAV SW CRANIAL 7.8 TO 7.9 , Serial Numbers: 000000003270709001 , 000000003428909001 , 000000004577510001 ;  44) Model 71067A , UPDATE VV NAV SW CRANIAL 7.8 TO 7.9.1 , Serial Numbers: 000000000253112001 , 000000000452712001 , 000000001446312001 , 000000001533312001 , 000000001708612001 , 000000002492312001 , 000000004691813001 , 000000009147012001 , 000000009537312001 , 000000009641812001 , 000000009653312001 ;  45) Model 71069 , UPD KOLIBRI NAV SW CRANIAL 2.6 TO 2.7 , Serial Numbers: 000000003189109001 ,  000000003189209001 , 000000003200109001 , 000000003288809001 , 000000003498009001 , 000000004323109001 , 000000004576710001 , 000000006333310001 , 000000006333410001 ;  46) Model 71075 , UPG CRA ESS 1.0 FROM ANY PREV. KOL SW , Serial Number: 000000005026310001 ;  47) Model 71076 , UPG VV CRA 7.0 FROM ANY PREV. VV CRA SW , Serial Number: 000000007742711001 ;  48) Model 71077 , UPG CRA UNL 1.0 FROM VV CRA 7.X , Serial Numbers: 000000005437910001 , 000000005587010001 , 000000006351510001 ;  49) Model 71077A , UPGRADE CRANIAL UNL 1.0.1 FROM VV 7.X , Serial Numbers: 000000002989913001 ,  000000002990013001 , 000000007676711001 , 000000008849411001 , 000000009150612001 ;  50) Model 71086 , UPG TO CRANIAL NAV SW 2.X FROM ANY PREV , Serial Numbers: 000000000110212001 , 000000000268812001 , 000000000268912001 , 000000000269112001 , 000000000306812001 , 000000000317512001 , 000000000420912001 , 000000000564112001 , 000000000627612001 , 000000000776012001 , 000000000837012001 , 000000001030812001 , 000000001157712001 , 000000001489112001 , 000000001510112001 , 000000001694212001 , 000000002957213001 , 000000004002213001 , 000000007487311001 , 000000007494511001 , 000000007561011001 , 000000007584811001 , 000000007754211001 , 000000007766011001 , 000000007832511001 , 000000007896911001 , 000000008147311001 , 000000008292611001 , 000000008312911001 , 000000008537511001 , 000000008610611001 , 000000008623211001 , 000000008626411001 , 000000008655511001 , 000000008796311001 , 000000008891611001 , 000000009025612001 , 000000009232112001 , 000000009301712001 , 000000009388712001 , 000000009537112001 , 000000009737712001 , 000000009737712002 , 000000009737712003 , 000000009856112001 , 000000009900812001 , 000000009904912001 , 000000009988512001 , 000000009991312001 , 000000009991412001 ;  51) Model 71086A , UPG TO CRANIAL NAV SW 2.X FROM ANY PREV , Serial Numbers: 000000002036914001 , 000000002344114001 , 000000004470113001 , 000000004507013001 , 000000004507113001 , 000000004918215001 , 000000005094113001 , 000000005658713001 , 000000006162913001 , 000000007326413001 , 000000007513413001 , 000000007870114001 , 000000008813214001 , 000000009479914001 ;  52) Model 71088 , UPGR TO CRANIAL NAV SW 2.X 11-02-18JUG2 , Serial Numbers: 000000007578911001 , 000000007626611001 ;  53) Model 71093 , GEN UPG CRANIAL NAV SW FOR CURVE , Serial Numbers: 000000000350812001 , 000000000619012001 , 000000000645412001 , 000000000676712001 , 000000000957112001 , 000000001091112001 , 000000001726912001 , 000000001727012001 , 000000002541512001 , 000000002583812001 , 000000002765713001 , 000000003236413001 , 000000003237213001 , 000000009412112001 , 000000009626512001 , 000000009669712001 , 000000009700112001 ;  54) Model 71093A , GEN UPG CRANIAL NAV SW FOR CURVE/KICK , Serial Numbers: 000000000494614001 , 000000001210114001 , 000000001239214001 , 000000002580914001 , 000000003754914001 , 000000003828313001 , 000000004239713001 , 000000004315913001 , 000000004591713001 , 000000004606413001 , 000000004785513001 , 000000004881313001 , 000000005430113001 , 000000005602113001 , 000000005602213001 , 000000005658813001 , 000000005658913001 , 000000005669013001 , 000000005982813001 , 000000006044113001 , 000000006044213001 , 000000006395013001 , 000000006395113001 , 000000006501913001 , 000000006643113001 , 000000006738213001 , 000000006878013001 , 000000007095113001 , 000000007095213001 , 000000007223613001 , 000000007248815001 , 000000007377813001 , 000000007487813001 , 000000007641214001 , 000000007641314001 , 000000007819514001 , 000000007844914001 , 000000007931414001 , 000000008021914001 , 000000008260014001 , 000000008296214001 , 000000008319314001 , 000000008454614001 , 000000008500114001 , 000000008795614001 , 000000008860614001 , 000000008860714001 , 000000008878214001 , 000000009480014001 ;  55) Model 71096 , UPG TO CRAN 2.x CURVE FROM CRAN UNL 1.0 , Serial Numbers: 000000000239112001 ,  000000000239212001 , 000000000239312001 , 000000000330112001 , 000000000789212001 , 000000000789312001 , 000000000998012001 , 000000001081912001 , 000000001186712001 , 000000001231712001 , 000000001352512001 , 000000001620512001 , 000000001706812001 , 000000001749112001 , 000000001895012001 , 000000002056312001 , 000000002098912001 , 000000002235012001 , 000000002235112001 , 000000002360412001 , 000000002696813001 , 000000002777313001 , 000000002777413001 , 000000002878213001 , 000000003057013001 , 000000003261813001 , 000000003314513001 , 000000003450613001 , 000000003450713001 , 000000003450813001 , 000000003602013001 , 000000003609213001 , 000000003609313001 , 000000003609413001 , 000000003666113001 , 000000009232212001 , 000000009389912001 , 000000009530112001 , 000000009764012001 ;  54) Model 71096A , UPG TO CRAN 2.x CURVE FROM CRAN UNL 1.0 , Serial Numbers: 000000001634614001 , 000000002290314001 , 000000003924813001 , 000000003960613001 , 000000003960713001 , 000000004303913001 , 000000004533313001 , 000000005397113001 , 000000005503813001 , 000000005535413001 , 000000006656213001 , 000000006894413001 , 000000006894513001 , 000000006941613001 , 000000007196713001 , 000000007365713001 , 000000007595914001 , 000000007927114001 , 000000008479114001 , 000000008543914001 , 000000009189414001 , 000000009189514001 , 000000009485314001 , 000000009564714001 , 000000009564814001 , 000000009908214001 , 000000009987114001 ;  55) Model 71097 , UPG TO CRAN 2.X CURVE FROM CRAN 2.X STD , Serial Numbers: 000000001620412001 , 000000001662512001 , 000000003087513001 , 000000003756313001 , 000000008548011001 ;  56) Model 71097A , UPG TO CRAN 2.X CURVE FROM CRAN 2.X STD , Serial Numbers: 000000001887414001 , 000000002536114001 , 000000004403613001 , 000000005779713001 , 000000006658513001 , 000000007168513001 , 000000007181513001 , 000000007418613001 , 000000007707214001 , 000000008465014001
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-Palme-Strasse 9
Munich Germany
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 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 actions to be taken. The customers were instructed to adhere to the measures described in document Measures to Improve Cranial Navigation Accuracy in the Product Notification letter when using the Brainlab Cranial Navigation System. Brainlab is requesting that 1. Existing potentially affected customers receive this Product Notification Letter. 2. These customers receive the attached supplement to the Instructions for Use regarding the Brainlab Cranial Navigation System in hardcopy version as an amendment to their current User Manuals. Tentative planned timeline for availability: June 2013 Additionally to advise the appropriate personnel working in your department of the content of Product Notification letter. If the medical users have the need for further clarification, they are asked to contact their local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by E-mail: support@brainlab.com. Fax Brainlab AG: + 49 89 99 15 68 33 Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany.
Quantity in Commerce 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = BRAINLAB AG
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