Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Depa...
FDA Device Recall #Z-0598-2016 — Class I — April 22, 2013
Recall Summary
| Recall Number | Z-0598-2016 |
| Classification | Class I — Serious risk |
| Date Initiated | April 22, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Brainlab AG |
| Location | Munich, N/A |
| Product Type | Devices |
| Quantity | 2528 units / 2119 consignees |
Product Description
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.
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.
Distribution Pattern
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.
Lot / 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 , 00000
Other Recalls from Brainlab AG
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1392-2025 | Class II | Origin Data Management software versions 3.1.0,... | Feb 10, 2025 |
| Z-1292-2023 | Class II | Cirq Arm System 2.0 | Mar 2, 2023 |
| Z-1259-2023 | Class II | Brainlab ExacTrac Dynamic software, Medical Cha... | Feb 14, 2023 |
| Z-0733-2022 | Class II | ExacTrac Dynamic software model numbers: 209... | Feb 25, 2022 |
| Z-1846-2021 | Class II | ExacTrac Dynamic software, Model 20910-01B ETD ... | May 14, 2021 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.