Date Initiated by Firm | June 21, 2018 |
Date Posted | July 10, 2018 |
Recall Status1 |
Terminated 3 on August 19, 2020 |
Recall Number | Z-2415-2018 |
Recall Event ID |
80433 |
PMA Number | P010015 |
Product Classification |
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
|
Product | Percepta Quad CRT-P MRI SureScan, REF W4TR04
Product Usage:
The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block. |
Code Information |
GTIN/UPN: (a) 00643169735705 Serial Numbers: RNV601570S RNV601571S RNV601972S RNV603768S RNV603769S RNV603802S RNV602113S RNV603803S RNV603804S RNV603805S RNV603806S RNV603807S RNV603809S RNV603813S RNV603815S RNV603821S RNV603822S RNV603830S RNV603831S RNV603850S RNV603877S RNV603879S RNV603458S RNV603260S RNV603476S RNV603477S RNV603209S RNV603032S RNV602351S RNV603137S RNV603231S RNV603232S RNV602932S RNV602933S RNV602934S RNV602950S RNV602952S RNV602953S RNV602956S RNV602958S RNV602960S RNV602966S RNV602974S RNV602975S RNV602977S RNV603843S RNV603845S RNV601392S RNV601414S RNV601558S RNV601561S RNV601562S RNV601563S RNV601564S RNV601565S RNV601566S RNV601567S RNV601568S RNV601569S RNV601572S RNV601573S RNV601574S RNV601575S RNV601591S RNV601592S RNV601594S RNV601595S RNV601596S RNV601597S RNV601598S RNV601599S RNV601600S RNV601603S RNV601617S RNV601618S RNV601619S RNV601620S RNV601621S RNV601673S RNV601817S RNV601934S RNV601935S RNV601936S RNV601937S RNV601938S RNV601940S RNV601941S RNV601942S RNV601949S RNV601983S RNV601984S RNV601985S RNV601986S RNV601987S RNV601988S RNV601989S RNV601990S RNV601992S RNV601993S RNV601994S RNV601996S RNV601997S RNV601998S RNV601999S RNV602000S RNV602119S RNV602305S RNV602383S RNV603345S RNV603365S RNV603369S RNV603693S RNV603703S RNV603704S RNV603705S RNV603706S RNV603707S RNV603737S RNV603982S RNV603983S RNV603984S RNV603985S RNV603986S RNV603987S RNV603988S RNV603989S RNV603990S RNV603991S RNV603992S RNV603993S RNV603994S RNV603995S RNV603996S RNV603997S RNV603998S RNV603999S RNV604000S RNV604001S RNV604003S RNV604004S RNV604005S RNV604006S RNV604007S RNV604008S RNV604009S RNV604010S RNV604011S RNV604012S RNV602341S RNV601850S RNV602343S RNV602345S RNV602353S RNV602355S RNV602359S RNV603005S RNV603011S RNV603018S RNV603024S RNV603029S RNV603031S RNV603033S RNV603034S RNV603039S RNV603041S RNV603042S RNV603273S RNV603275S RNV603276S RNV603348S RNV602749S RNV603195S RNV603218S RNV603221S RNV603222S RNV603224S RNV603225S RNV603226S RNV603481S RNV603482S RNV603511S RNV603512S RNV603516S RNV603517S RNV603518S RNV603520S RNV603521S RNV603523S RNV603524S RNV603526S RNV603538S RNV603540S RNV603560S RNV603574S RNV603582S RNV601835S RNV601842S RNV601871S RNV601833S RNV601845S RNV601851S RNV601852S RNV602346S RNV603036S RNV603474S RNV603475S RNV603501S RNV603844S RNV603846S RNV603847S RNV603848S RNV603849S RNV603851S RNV603852S RNV603853S RNV603854S RNV603855S RNV603856S RNV603857S RNV603858S RNV603859S RNV603860S RNV603862S RNV603863S RNV603864S RNV603865S RNV603866S RNV603867S RNV603868S RNV603869S RNV603870S RNV603871S RNV603872S RNV603873S RNV603874S RNV603875S RNV603876S RNV603878S RNV603880S RNV603881S RNV603883S RNV603884S RNV603886S RNV603887S RNV603889S RNV603890S RNV603891S RNV603892S RNV603893S RNV603896S RNV603897S RNV603898S RNV603899S RNV603900S RNV603901S RNV603903S RNV603904S RNV603905S RNV603906S RNV603907S RNV603908S RNV603909S RNV603910S RNV603911S RNV603912S RNV603913S RNV603914S RNV603915S RNV603916S RNV603917S RNV603918S RNV603919S RNV603920S RNV603922S RNV603923S RNV603924S RNV603925S RNV603926S RNV603927S RNV603928S RNV603929S RNV603930S RNV603931S RNV603932S RNV603934S RNV603935S RNV603938S RNV603939S RNV603940S RNV603943S RNV603945S RNV603946S RNV603947S RNV603948S RNV603949S RNV603952S RNV603954S RNV603955S RNV603956S RNV603957S RNV603958S RNV603959S RNV603960S RNV603961S RNV603962S RNV603963S RNV603964S RNV603965S RNV603966S RNV603967S RNV603968S RNV603969S RNV603970S RNV603971S RNV603972S RNV603974S RNV604002S RNV604013S RNV604014S RNV604015S RNV604016S RNV604017S RNV604018S RNV604019S RNV604020S RNV604021S RNV604022S RNV604023S RNV604024S RNV604025S RNV604026S RNV604027S RNV604028S RNV604029S RNV604030S RNV604031S RNV604032S RNV604033S RNV604034S RNV604035S RNV604036S RNV604037S RNV604038S RNV604039S RNV604040S RNV604041S RNV604042S RNV604043S RNV604044S RNV604045S RNV604046S RNV604047S RNV604048S RNV604049S RNV604050S RNV604051S RNV604052S RNV604054S RNV604055S RNV604056S RNV604057S RNV604058S RNV604059S RNV604060S RNV604061S RNV604062S RNV604063S RNV604064S RNV604065S RNV604066S RNV604067S RNV604068S RNV604069S RNV604070S RNV604071S RNV604072S RNV604073S RNV604074S RNV604075S RNV604076S RNV604077S RNV604078S RNV604079S RNV604080S RNV604081S RNV604082S RNV604083S RNV604084S RNV604085S RNV604086S RNV604087S RNV604088S RNV604089S RNV604090S RNV604091S RNV604092S RNV604093S RNV604094S RNV604095S RNV604096S RNV604097S RNV604098S RNV604099S RNV604100S RNV604101S RNV604102S RNV604103S RNV604104S RNV604105S RNV604106S RNV604107S RNV604108S RNV604109S RNV604110S RNV604111S RNV604112S RNV604113S RNV604114S RNV604115S RNV604117S RNV604118S RNV604119S RNV604120S RNV604121S RNV604122S RNV602951S RNV602954S RNV602959S RNV602970S RNV602009S RNV604116S RNV601176S RNV601747S RNV602008S RNV602399S RNV602400S RNV603581S RNV603527S RNV603479S RNV601707S RNV601381S RNV603839S RNV603840S RNV601122S RNV603657S RNV603694S RNV601772S RNV602505S RNV602137S RNV602615S RNV601646S RNV601709S RNV602149S RNV603763S RNV603147S RNV602907S RNV603760S RNV603506S RNV603406S RNV603978S RNV602303S RNV603052S RNV601240S RNV601527S RNV602306S RNV602510S RNV602962S RNV601276S RNV601279S RNV603493S RNV603317S RNV603206S RNV603207S RNV603025S RNV601493S RNV601469S RNV603163S RNV601181S RNV601182S RNV603043S RNV601358S RNV601359S RNV601190S RNV603510S RNV603698S RNV601193S RNV601479S RNV602598S RNV603316S RNV603320S RNV601145S RNV603882S RNV601188S RNV603237S RNV602591S RNV602617S RNV603324S RNV601434S RNV601615S RNV603295S RNV603296S RNV602112S RNV601476S RNV601477S RNV602522S RNV602523S RNV601971S RNV602553S RNV602348S RNV602942S RNV601779S RNV603976S RNV603977S RNV603463S RNV603318S RNV603491S RNV603799S RNV603584S RNV603210S RNV603211S RNV603979S RNV601478S RNV601514S RNV601457S RNV602768S RNV603483S RNV602592S RNV603051S RNV602819S RNV602379S RNV601899S RNV601900S RNV602101S RNV602293S RNV603812S RNV603515S RNV602995S RNV603010S RNV603490S RNV601800S RNV601267S RNV601529S RNV603826S RNV602590S RNV602621S RNV602769S RNV601480S RNV603981S RNV603446S RNV602058S RNV603086S RNV603400S RNV601537S RNV601687S RNV602108S RNV601678S RNV601536S RNV602362S RNV602637S RNV603202S RNV602259S RNV602263S RNV603390S RNV603478S RNV603110S RNV603502S RNV603175S RNV603176S RNV603177S RNV603256S RNV602300S RNV601862S RNV602139S RNV602910S RNV603171S RNV602111S RNV603142S RNV601624S RNV601445S RNV602552S RNV602742S RNV601752S RNV601766S RNV601769S RNV602020S RNV602358S RNV602361S RNV601168S RNV601013S RNV601148S RNV601464S RNV601846S RNV602537S RNV602585S RNV602782S RNV602844S RNV603448S RNV602284S RNV601352S RNV601380S RNV601733S RNV601897S RNV602138S RNV602152S RNV602241S RNV602853S RNV603139S RNV603585S RNV603643S RNV603673S RNV603674S RNV602065S RNV602242S RNV602243S RNV602849S RNV603738S RNV601732S RNV602315S RNV601451S RNV601920S RNV602053S RNV602445S RNV602464S RNV603000S RNV602141S RNV603980S RNV603442S RNV603445S RNV601751S RNV601853S RNV602004S RNV602003S RNV602938S RNV601744S RNV600966S RNV600764S RNV600972S RNV600977S RNV600982S RNV600984S RNV600987S RNV602005S RNV602006S RNV600766S RNV601149S RNV601165S RNV601754S RNV601759S RNV602365S RNV602928S RNV601463S RNV602397S RNV601144S RNV601461S RNV603192S RNV603391S RNV603393S RNV603394S RNV603395S RNV601773S RNV601774S RNV601775S RNV601776S RNV601778S RNV601780S RNV601781S RNV601783S RNV601785S RNV601787S RNV601788S RNV601793S RNV601795S RNV601799S RNV601805S RNV601808S RNV601816S RNV601823S RNV601824S RNV601825S RNV601826S RNV601827S RNV601828S RNV601829S RNV601830S RNV602491S RNV603731S RNV601811S RNV602161S RNV602162S RNV602434S RNV602571S RNV602589S RNV603702S RNV601002S RNV601333S RNV601374S RNV601038S RNV602416S RNV602134S RNV602244S RNV602626S RNV603062S RNV603289S RNV602735S RNV602737S RNV602739S RNV602153S RNV602156S RNV602254S RNV602255S RNV602256S RNV602669S RNV602670S RNV602671S RNV602672S RNV602673S RNV602674S RNV602675S RNV602677S RNV602688S RNV602690S RNV603814S RNV601036S RNV601263S RNV601265S RNV601266S RNV601271S RNV601293S RNV601294S RNV601443S RNV601444S RNV601660S RNV601919S RNV602074S RNV602075S RNV602158S RNV602159S RNV602160S RNV602396S RNV602476S RNV602477S RNV602478S RNV602479S RNV602721S RNV602722S RNV602820S RNV602821S RNV602822S RNV602824S RNV602825S RNV602826S RNV602827S RNV602828S RNV602989S RNV602990S RNV603066S RNV603067S RNV603068S RNV603096S RNV603097S RNV603098S RNV603099S RNV603100S RNV603101S RNV603102S RNV603103S RNV603111S RNV603112S RNV603113S RNV603114S RNV603187S RNV603188S RNV603189S RNV603190S RNV603191S RNV603193S RNV603194S RNV603198S RNV603199S RNV603385S RNV603386S RNV603389S RNV603435S RNV603531S RNV603532S RNV603533S RNV603534S RNV603717S RNV603733S RNV603734S RNV603735S RNV603736S RNV601135S RNV601136S RNV601280S RNV603130S RNV603131S RNV603132S RNV603133S RNV603134S RNV602308S RNV601031S RNV602635S RNV602746S RNV602788S RNV603650S RNV603651S RNV603652S RNV603653S RNV603654S RNV600973S RNV600974S RNV601057S RNV601204S RNV601207S RNV601292S RNV601299S RNV601328S RNV601344S RNV601365S RNV601387S RNV601398S RNV601679S RNV601893S RNV601894S RNV602322S RNV602390S RNV602402S RNV602432S RNV602443S RNV602695S RNV602709S RNV602744S RNV602745S RNV602765S RNV602772S RNV603064S RNV603160S RNV603287S RNV603359S RNV603408S RNV603436S RNV603539S RNV603634S RNV603709S RNV603745S RNV601758S RNV601760S RNV601761S RNV601762S RNV601763S RNV601764S RNV601765S RNV601767S RNV601768S RNV601770S RNV603374S RNV603470S RNV603472S RNV600971S RNV601113S RNV601138S RNV601139S RNV601247S RNV601278S RNV601325S RNV601559S RNV601664S RNV601693S RNV601694S RNV601695S RNV601696S RNV601697S RNV601877S RNV601922S RNV602588S RNV602691S RNV602767S RNV602987S RNV603125S RNV603126S RNV603156S RNV603157S RNV603290S RNV603528S RNV603529S RNV603530S RNV603631S RNV603659S RNV603777S RNV603786S RNV601104S RNV601105S RNV601106S RNV601609S RNV601610S RNV601611S RNV601612S RNV602170S RNV602339S RNV602446S RNV602450S RNV602716S RNV602717S RNV602718S RNV602719S RNV602785S RNV603412S RNV603413S RNV601192S RNV601602S RNV602448S RNV602449S RNV603842S RNV601254S RNV601286S RNV601289S RNV601290S RNV601291S RNV602839S RNV603109S RNV601540S RNV602547S RNV602557S RNV602646S RNV602698S RNV602756S RNV602883S RNV602913S RNV603285S RNV603437S RNV603573S RNV603828S RNV601690S RNV602786S RNV602157S RNV601114S RNV601134S RNV601189S RNV601194S RNV601351S RNV602659S RNV601248S RNV601326S RNV601327S RNV601397S RNV601427S RNV601428S RNV602088S RNV602430S RNV602431S RNV603816S RNV600961S RNV600962S RNV600963S RNV601101S RNV601277S RNV601901S RNV602408S RNV602409S RNV602462S RNV602711S RNV602712S RNV602713S RNV602715S RNV603548S RNV603563S RNV603564S RNV603645S RNV603646S RNV603647S RNV603827S RNV601060S RNV601109S RNV601155S RNV601171S RNV601172S RNV601173S RNV601174S RNV601175S RNV601178S RNV601210S RNV602573S RNV602574S RNV602575S RNV602579S RNV602583S RNV602627S RNV602629S RNV602630S RNV602632S RNV603414S RNV603415S RNV603416S RNV603417S RNV603418S
RNV603419S RNV603420S RNV603421S RNV603422S RNV603424S RNV603838S RNV603832S RNV603833S RNV601924S RNV601925S RNV601926S RNV601927S RNV602077S RNV602078S RNV602392S RNV602699S RNV602700S RNV602701S RNV602702S RNV603208S RNV603212S RNV603213S RNV603219S RNV603498S RNV603555S RNV603556S RNV603571S RNV603667S RNV603668S RNV603149S RNV601102S RNV601103S RNV602370S RNV602372S RNV603741S RNV602841S RNV603063S RNV603559S RNV603561S RNV603834S RNV602602S RNV602605S RNV602606S RNV602608S RNV602609S RNV601685S RNV601686S RNV602941S RNV603013S RNV601895S RNV601928S RNV602033S RNV602034S RNV602380S RNV601656S RNV601902S RNV601904S RNV601906S RNV601907S RNV602495S RNV602497S RNV602499S RNV602500S RNV602503S RNV602504S RNV602506S RNV602513S RNV602957S RNV603001S RNV603002S RNV603003S RNV603004S RNV603205S RNV603680S RNV603681S RNV603682S RNV603683S RNV603684S RNV603685S RNV603686S RNV603687S RNV603688S RNV603689S RNV603690S RNV603691S RNV603692S RNV601323S RNV603072S RNV603165S RNV603620S RNV602174S RNV602316S RNV602317S RNV602733S RNV602908S RNV602912S RNV601239S RNV601257S RNV601259S RNV601908S RNV602278S RNV602444S RNV602451S RNV602805S RNV602986S RNV603204S RNV603696S RNV603697S RNV602466S RNV603279S RNV603580S RNV601748S RNV602356S RNV602507S RNV603090S RNV603154S RNV602320S RNV602596S RNV602599S RNV602601S RNV602755S RNV602869S RNV602982S RNV602985S RNV603808S RNV601585S RNV601586S RNV602720S RNV602770S RNV603284S RNV603455S RNV603456S RNV601865S RNV601876S RNV601885S RNV601905S RNV601932S RNV603214S RNV603215S RNV601353S RNV603058S RNV603352S RNV603810S RNV601342S RNV601343S RNV601689S RNV602127S RNV603119S RNV603167S RNV603746S RNV601391S RNV602818S RNV603220S RNV603261S RNV603820S RNV601616S RNV603836S RNV601607S RNV601608S RNV601710S RNV602037S RNV602051S RNV602109S RNV602262S RNV602447S RNV602543S RNV602568S RNV602643S RNV602787S RNV603106S RNV603309S RNV603562S RNV603633S RNV603788S RNV602039S RNV602881S RNV603148S RNV603141S RNV603895S RNV601448S RNV603452S RNV603466S RNV603467S RNV603468S RNV603469S RNV603825S RNV601212S RNV601214S RNV601215S RNV601217S RNV601218S RNV601220S RNV601221S RNV601222S RNV601224S RNV601225S RNV601226S RNV601227S RNV601228S RNV601229S RNV601232S RNV601234S RNV601235S RNV601236S RNV601237S RNV601238S RNV603779S RNV601415S RNV601416S RNV601417S RNV601418S RNV601419S RNV602520S RNV602526S RNV602527S RNV602528S RNV602530S RNV602531S RNV602533S RNV602866S RNV602867S RNV601931S RNV602086S RNV601652S RNV602091S RNV602730S RNV603120S RNV603255S RNV603338S RNV603823S RNV603824S RNV603283S RNV603618S RNV603572S RNV601187S RNV601400S RNV601401S RNV601402S RNV601403S RNV602732S RNV603179S RNV603180S RNV603181S RNV603182S RNV603183S RNV603282S RNV600983S RNV600985S RNV600986S RNV600988S RNV600989S RNV600992S RNV600993S RNV600994S RNV600995S RNV600997S RNV601163S RNV601230S RNV601231S RNV601241S RNV601242S RNV601878S RNV602115S RNV602116S RNV602117S RNV602266S RNV602267S RNV602269S RNV602271S RNV602273S RNV602274S RNV602276S RNV602889S RNV602890S RNV602891S RNV603044S RNV603045S RNV603327S RNV603328S RNV603329S RNV603330S RNV603331S RNV603332S RNV603333S RNV603334S RNV603335S RNV603336S RNV603473S RNV603764S RNV603765S RNV603766S RNV603297S RNV603298S RNV603299S RNV603300S RNV603301S RNV603811S RNV600970S RNV601115S RNV601345S RNV601875S RNV601884S RNV602164S RNV602644S RNV603281S RNV601034S RNV601152S RNV601156S RNV601157S RNV601158S RNV601159S RNV601160S RNV601298S RNV601874S RNV602437S RNV602439S RNV602705S RNV603073S RNV603081S RNV603082S RNV603351S RNV601191S RNV601252S RNV601253S RNV601357S RNV601386S RNV601677S RNV602042S RNV602045S RNV602046S RNV602047S RNV602048S RNV602049S RNV602050S RNV602618S RNV602620S RNV603227S RNV603230S RNV603235S RNV603236S RNV603238S RNV603245S RNV603247S RNV603249S RNV603251S RNV602586S RNV601014S RNV601016S RNV601018S RNV602859S RNV602860S RNV602861S RNV602862S RNV602863S RNV602864S RNV603829S RNV601820S RNV601821S RNV602829S RNV603095S RNV603615S RNV603679S RNV602452S RNV601725S RNV601726S RNV601727S RNV601728S RNV601729S RNV602535S RNV602538S RNV602539S RNV602540S RNV602542S RNV602545S RNV602546S RNV602548S RNV602549S RNV602550S RNV603587S RNV603588S RNV603589S RNV603590S RNV603591S RNV603217S RNV603444S RNV600999S RNV601211S RNV601255S RNV601256S RNV601260S RNV601261S RNV601330S RNV601331S RNV601349S RNV601404S RNV601453S RNV601456S RNV601632S RNV601658S RNV601803S RNV601813S RNV602070S RNV602245S RNV602246S RNV602401S RNV602417S RNV602454S RNV602488S RNV602638S RNV602678S RNV602779S RNV602780S RNV602781S RNV602790S RNV602791S RNV602816S RNV603047S RNV603048S RNV603122S RNV601201S RNV603818S RNV603819S RNV601243S RNV601244S RNV601771S RNV603936S RNV603937S RNV603941S RNV603942S RNV603944S RNV603950S RNV603951S RNV603953S RNV603973S RNV603975S RNV602508S RNV602518S RNV602991S RNV602992S RNV602993S RNV602996S RNV602997S RNV603009S RNV603449S RNV603451S RNV603453S RNV603454S RNV603457S RNV603495S RNV603497S RNV603500S RNV603503S RNV603504S RNV603505S RNV603771S RNV603774S RNV603776S RNV603778S RNV603789S RNV602132S RNV602280S RNV602980S RNV603135S RNV601410S RNV601546S RNV601560S RNV601839S RNV602285S RNV602292S RNV603079S RNV603080S RNV603783S RNV601460S RNV602010S RNV603835S RNV601580S RNV601655S RNV601213S RNV601216S RNV601422S RNV601468S RNV601519S RNV601947S RNV602426S RNV602561S RNV602013S RNV601288S RNV601318S RNV602314S RNV602529S RNV602972S RNV602976S RNV601268S RNV601980S RNV601008S RNV602511S RNV602582S RNV601027S RNV602501S RNV601499S RNV602378S RNV600996S RNV602018S RNV600991S RNV603201S RNV603319S RNV601495S RNV602014S RNV602587S RNV601047S RNV601269S RNV601956S RNV602323S RNV601270S RNV601272S RNV601274S RNV601275S RNV601508S RNV601524S RNV601526S RNV602420S RNV602516S RNV602597S RNV602750S RNV602758S RNV602946S RNV601022S RNV601032S RNV601258S RNV602967S RNV601208S RNV601264S RNV601321S RNV601466S RNV601487S RNV601507S RNV601512S RNV601513S RNV601521S RNV602017S RNV602736S RNV601436S RNV601944S RNV601973S RNV601206S RNV601472S RNV601004S RNV601046S RNV601504S RNV602371S RNV602493S RNV603070S RNV602766S RNV602971S RNV601531S RNV601532S RNV602425S RNV603173S RNV603174S RNV601954S RNV602489S RNV601470S RNV601474S RNV601953S RNV602943S RNV601223S RNV601233S RNV601483S RNV601525S RNV602369S RNV602521S RNV602614S RNV602679S RNV602762S RNV601485S RNV601509S RNV602517S RNV602373S RNV602514S RNV601021S RNV601029S RNV602525S RNV602694S RNV601502S RNV601960S RNV602302S RNV602367S RNV602947S RNV601523S RNV601966S RNV601970S RNV602681S RNV601315S RNV601304S RNV601311S RNV601955S RNV601982S RNV601025S RNV601026S RNV601510S RNV602015S RNV601185S RNV601528S RNV602773S RNV601481S RNV601052S RNV601362S RNV601501S RNV601959S RNV601979S RNV603053S RNV603169S RNV601183S RNV603658S RNV601130S RNV601371S RNV601147S RNV601843S RNV602011S RNV603513S RNV603376S RNV602703S RNV603108S RNV603678S RNV603748S RNV603749S RNV603750S RNV603751S RNV603752S RNV603753S RNV601023S RNV601024S RNV601467S RNV602415S RNV602433S RNV602682S RNV603375S RNV603677S RNV603791S RNV601535S RNV600965S RNV602281S RNV601203S RNV602301S RNV602924S RNV602925S RNV602926S RNV602927S RNV602929S RNV602930S RNV602931S RNV603837S RNV603817S RNV603552S RNV603669S RNV603014S RNV603357S RNV601818S RNV603071S RNV602519S RNV603136S RNV603040S RNV603277S RNV603278S RNV603841S RNV603885S RNV603888S RNV603894S RNV603902S RNV603921S RNV603933S RNV601819S RNV601832S RNV601837S RNV601838S RNV601840S RNV601841S RNV601847S RNV601849S RNV601854S RNV601855S RNV601857S RNV601858S RNV601859S RNV601860S RNV601861S RNV601863S RNV601864S RNV601866S RNV601867S RNV601868S RNV601869S RNV601870S RNV601872S RNV601873S RNV602342S RNV602349S RNV602350S RNV602352S RNV602357S RNV603006S RNV603007S RNV603008S RNV603015S RNV603016S RNV603017S RNV603020S RNV603021S RNV603023S RNV603274S RNV603347S RNV603349S RNV603350S RNV603355S RNV603356S RNV603423S RNV603613S RNV603708S RNV601475S RNV601010S RNV601473S RNV601522S RNV601143S RNV601166S RNV601177S RNV601200S RNV601297S RNV601360S RNV601370S RNV601550S RNV601739S RNV601742S RNV601743S RNV601746S RNV602059S RNV602060S RNV602062S RNV602063S RNV602222S RNV602294S RNV602634S RNV602723S RNV602724S RNV602725S RNV603093S RNV603094S RNV603310S RNV603311S RNV603312S RNV603313S RNV601179S RNV601505S RNV601506S RNV603059S RNV602624S RNV602973S RNV603128S RNV603228S RNV601219S RNV601520S RNV601303S RNV601306S RNV601309S RNV601310S RNV601312S RNV601313S RNV601316S RNV601388S RNV601405S RNV601412S RNV601952S RNV601967S RNV601981S RNV602404S RNV602412S RNV602424S RNV602463S RNV602480S RNV602532S RNV602684S RNV602728S RNV602823S RNV602944S RNV601039S RNV601554S RNV601593S RNV601681S RNV601712S RNV601713S RNV601714S RNV601921S RNV602858S RNV602905S RNV602906S RNV603323S RNV603551S RNV603583S RNV601307S RNV601308S RNV601384S RNV601421S RNV601964S RNV602616S RNV602777S RNV602783S RNV602798S RNV601450S RNV601557S RNV603151S RNV603382S RNV601195S RNV601196S RNV602685S RNV602687S RNV602807S RNV602808S RNV602809S RNV602810S RNV603266S RNV601672S RNV603553S RNV603407S RNV603742S RNV601338S RNV601341S RNV601627S RNV601556S RNV601914S RNV602757S RNV601395S RNV601396S RNV602032S RNV602068S RNV602275S RNV602471S RNV602794S RNV603280S RNV603462S RNV602286S RNV603123S RNV601711S RNV602838S RNV603541S RNV601438S RNV601439S RNV601452S RNV602291S RNV602922S RNV602923S RNV603384S RNV603772S RNV601430S RNV602130S RNV602686S RNV602936S RNV603744S RNV602082S RNV602103S RNV602104S RNV601399S RNV602901S RNV603242S RNV601048S RNV601049S RNV602440S RNV603339S RNV602470S RNV601454S RNV602318S RNV602920S RNV601702S RNV601703S RNV601807S RNV602043S RNV602468S RNV602560S RNV602648S RNV603092S RNV601329S RNV601909S RNV601910S RNV602144S RNV603088S RNV603519S RNV601892S RNV602044S RNV602071S RNV602232S RNV602855S RNV601880S RNV602748S RNV601431S RNV601432S RNV601676S RNV603087S RNV603635S RNV601346S RNV601406S RNV601736S RNV602224S RNV603074S RNV603325S RNV603550S RNV603577S RNV603719S RNV603758S RNV601551S RNV601552S RNV601995S RNV602229S RNV602290S RNV602551S RNV603294S RNV603661S RNV603665S RNV603695S RNV601423S RNV601424S RNV602916S RNV601622S RNV601623S RNV601708S RNV602456S RNV602581S RNV602872S RNV602873S RNV603440S RNV601583S RNV601584S RNV602692S RNV603743S RNV601737S RNV601809S RNV602704S RNV602850S RNV601644S RNV601912S RNV602072S RNV602081S RNV602394S RNV603306S RNV601336S RNV601545S RNV602128S RNV602837S RNV603069S RNV601668S RNV601669S RNV603124S RNV602321S RNV602760S RNV602921S RNV601356S RNV602893S RNV602983S RNV602423S RNV602498S RNV603268S RNV601045S RNV602228S RNV601647S RNV601653S RNV602800S RNV602801S RNV602802S RNV602803S RNV603714S RNV603715S RNV603716S RNV601806S RNV601882S RNV602897S RNV603711S RNV603762S RNV601659S RNV602647S RNV601674S RNV602041S RNV602056S RNV603739S RNV602052S RNV602778S RNV601489S RNV602577S RNV602330S RNV602340S RNV602706S RNV602902S RNV603740S RNV602124S RNV602650S RNV602651S RNV603557S RNV603558S RNV603722S RNV602024S RNV601680S RNV602298S RNV602038S RNV603578S
RNV603579S RNV601056S RNV601814S RNV602107S RNV603575S RNV603576S RNV603747S RNV602395S RNV601789S RNV602035S RNV602389S RNV602726S RNV602978S RNV603569S RNV601625S RNV603166S RNV603246S RNV601896S RNV601898S RNV602125S RNV601429S RNV602133S RNV602223S RNV602465S RNV602856S RNV602998S RNV603184S RNV603340S RNV603509S RNV603793S RNV600969S RNV601665S RNV601666S RNV601667S RNV602055S RNV602097S RNV602335S RNV602771S RNV602854S RNV603116S RNV603168S RNV603441S RNV603486S RNV603632S RNV603655S RNV601407S RNV601408S RNV601409S RNV601923S RNV602030S RNV602414S RNV602584S RNV602660S RNV602848S RNV602937S RNV603732S RNV601588S RNV601670S RNV601730S RNV602120S RNV602410S RNV602562S RNV602595S RNV602894S RNV602896S RNV603085S RNV603267S RNV603326S RNV603367S RNV603675S RNV602564S RNV603262S RNV601661S RNV602344S RNV603370S RNV601449S RNV602270S RNV602328S RNV602813S RNV603258S RNV603759S RNV601791S RNV602741S RNV602743S RNV603487S RNV601350S RNV601683S RNV601684S RNV602102S RNV602282S RNV602576S RNV602578S RNV603507S RNV603554S RNV601339S RNV601704S RNV601705S RNV601706S RNV602099S RNV602121S RNV602486S RNV602696S RNV602710S RNV603257S RNV603641S RNV601335S RNV601688S RNV601796S RNV601883S RNV602031S RNV602085S RNV602233S RNV602272S RNV602422S RNV602481S RNV602707S RNV602708S RNV602888S RNV602948S RNV603076S RNV603115S RNV603140S RNV603401S RNV603405S RNV603434S RNV603718S RNV603780S RNV601642S RNV601643S RNV601810S RNV602028S RNV602163S RNV602386S RNV602413S RNV602536S RNV602658S RNV602661S RNV602697S RNV602797S RNV603091S RNV603522S RNV603542S RNV603543S RNV603545S RNV603546S RNV603547S RNV600975S RNV601005S RNV601059S RNV601161S RNV601249S RNV601250S RNV601822S RNV602265S RNV602419S RNV602796S RNV602799S RNV602857S RNV603341S RNV602994S RNV603396S RNV603636S RNV603712S RNV601848S RNV601834S RNV601844S RNV602279S RNV601802S RNV601801S RNV603342S RNV602123S RNV602311S RNV602388S RNV601355S RNV603060S RNV601322S RNV601425S RNV602067S RNV602310S RNV603077S RNV601446S RNV601363S RNV602852S RNV601541S RNV601542S RNV601757S RNV602940S RNV602868S RNV603402S RNV601538S RNV601553S RNV601581S RNV601582S RNV602022S RNV602105S RNV602106S RNV602406S RNV602428S RNV602436S RNV602438S RNV602441S RNV602485S RNV602502S RNV602541S RNV602556S RNV602631S RNV602761S RNV602784S RNV602812S RNV602870S RNV602871S RNV603078S RNV603104S RNV603105S RNV603118S RNV603127S RNV603259S RNV603303S RNV603314S RNV603315S RNV603321S RNV603492S RNV603544S RNV603662S RNV603664S RNV603676S RNV603721S RNV603787S RNV601447S RNV603757S RNV601648S RNV602492S RNV603371S RNV603494S RNV601721S RNV601722S RNV602122S RNV602129S RNV602384S RNV602427S RNV602657S RNV602729S RNV603381S RNV601649S RNV601041S RNV601042S RNV601043S RNV601044S RNV601413S RNV602090S RNV602155S RNV602403S RNV603158S RNV603159S RNV603272S RNV603409S RNV603670S RNV601548S RNV601549S RNV602625S RNV601146S RNV602079S RNV602080S RNV602100S RNV602642S RNV602898S RNV603241S RNV603305S RNV603761S RNV601393S RNV602569S RNV602914S RNV603794S RNV603700S RNV603701S RNV600967S RNV601116S RNV601117S RNV601140S RNV601141S RNV601332S RNV601698S RNV601699S RNV601700S RNV601701S RNV602623S RNV603291S RNV603292S RNV601300S RNV601301S RNV601777S RNV601917S RNV601918S RNV602364S RNV602393S RNV602474S RNV602662S RNV603185S RNV603288S RNV603346S RNV603373S RNV602002S RNV602374S RNV602375S RNV602376S RNV601017S RNV602955S RNV603233S RNV601199S RNV602309S RNV603616S RNV601945S RNV601946S RNV603186S RNV603234S RNV601302S RNV601314S RNV601962S RNV601283S RNV602363S RNV603488S RNV603790S RNV603489S RNV601645S RNV602354S RNV601951S RNV602633S RNV602753S RNV601753S RNV603443S RNV603461S RNV601133S RNV601368S RNV601394S RNV601815S RNV603107S RNV603614S RNV603644S RNV601511S RNV601518S RNV602534S RNV602295S RNV603229S RNV602918S RNV603754S RNV603755S RNV603269S RNV603270S RNV601496S RNV601503S RNV601968S RNV602368S RNV602963S RNV602964S RNV603057S RNV601604S RNV601671S RNV602148S RNV601543S RNV601544S RNV602175S RNV602319S RNV602645S RNV602811S RNV601613S RNV602131S RNV602249S RNV602250S RNV602469S RNV602475S RNV602628S RNV602663S RNV603061S RNV603155S RNV603265S RNV603403S RNV603663S RNV603666S RNV603730S RNV601180S RNV601317S RNV601319S RNV601433S RNV601492S RNV602969S RNV601555S RNV602040S RNV603380S RNV601324S RNV601497S RNV601455S RNV602603S RNV603699S RNV603480S RNV601379S RNV601383S RNV601903S RNV602213S RNV602214S RNV602215S RNV602216S RNV602217S RNV602218S RNV602219S RNV602220S RNV602221S RNV602236S RNV602237S RNV602238S RNV602239S RNV602324S RNV602325S RNV602326S RNV602327S RNV602329S RNV602331S RNV602332S RNV602333S RNV602334S RNV602336S RNV602337S RNV602338S RNV602407S RNV602461S RNV602484S RNV603447S RNV602555S RNV602622S RNV602636S RNV602653S RNV602654S RNV602655S RNV602656S RNV603035S RNV603038S RNV601001S RNV601020S RNV601340S RNV602165S RNV602166S RNV602167S RNV602168S RNV602169S RNV602171S RNV602831S RNV602833S RNV602834S RNV602835S RNV602836S RNV601587S RNV601337S RNV601320S RNV601209S RNV601576S RNV601577S RNV601578S RNV601662S RNV601812S RNV602069S RNV602094S RNV602136S RNV602459S RNV602467S RNV602734S RNV602911S RNV603129S RNV603164S RNV603264S RNV603637S RNV603729S RNV601831S RNV602304S RNV602984S RNV602230S RNV602277S RNV601856S RNV601361S RNV601367S RNV601682S RNV602027S RNV602084S RNV602087S RNV602299S RNV602554S RNV602580S RNV602851S RNV602874S RNV603143S RNV603271S RNV603372S RNV603471S RNV603496S RNV603656S RNV603671S RNV603713S RNV603775S RNV601579S RNV601663S RNV601692S RNV603203S RNV603619S RNV603638S RNV603639S RNV602935S RNV603343S RNV602225S RNV600765S RNV600990S RNV601782S RNV602007S RNV602016S RNV603197S RNV601033S RNV601471S RNV601515S RNV601053S RNV601054S RNV601055S RNV602178S RNV602179S RNV602180S RNV602181S RNV602182S RNV602183S RNV602184S RNV602185S RNV602186S RNV602187S RNV602875S RNV602876S RNV602877S RNV602878S RNV602879S RNV603353S RNV603354S RNV603397S RNV603398S RNV603399S RNV603425S RNV603426S RNV603427S RNV603428S RNV603429S RNV603430S RNV603431S RNV603432S RNV603535S RNV603536S RNV603621S RNV603622S RNV603623S RNV603624S RNV603625S RNV603626S RNV603627S RNV603628S RNV603629S RNV603630S RNV603027S RNV603253S RNV602494S RNV601441S RNV602001S RNV601169S RNV601170S RNV602472S RNV602473S RNV602842S RNV602843S RNV602845S RNV603049S RNV603055S RNV601003S RNV601516S RNV601050S RNV601051S RNV602610S RNV603617S RNV602347S RNV602381S RNV603153S RNV602429S RNV601153S RNV601691S RNV602227S RNV601123S RNV601150S RNV601420S RNV601794S RNV603170S RNV603648S RNV603649S RNV601273S RNV602482S RNV602759S RNV602961S RNV603019S RNV603361S RNV601539S RNV603362S RNV603363S RNV601635S RNV601636S RNV601637S RNV601638S RNV601639S RNV601640S RNV601641S RNV602025S RNV601118S RNV601119S RNV602076S RNV602377S RNV602382S RNV602619S RNV602789S RNV603138S RNV603304S RNV602683S RNV602738S RNV602832S RNV602840S RNV601124S RNV601373S RNV601589S RNV601590S RNV603672S RNV602257S RNV603286S RNV603150S RNV603465S RNV602747S RNV603146S RNV602231S RNV601125S RNV601916S RNV602064S RNV602251S RNV602261S RNV602297S RNV602880S RNV603514S RNV601035S RNV601245S RNV601246S RNV601251S RNV601364S RNV601411S RNV601442S RNV602150S RNV602247S RNV602385S RNV602435S RNV602442S RNV602453S RNV602804S RNV602830S RNV603089S RNV603387S RNV601000S RNV601482S RNV601517S RNV603485S RNV603800S RNV603801S RNV601465S RNV601498S RNV601950S RNV602676S RNV603026S RNV603054S RNV601963S RNV600998S RNV602083S RNV602904S RNV602114S RNV602154S RNV602252S RNV602460S RNV600979S RNV601126S RNV601142S RNV602151S RNV602307S RNV602814S RNV602036S RNV603322S RNV602145S RNV602146S RNV602287S RNV602421S RNV602593S RNV602806S RNV602988S RNV603383S RNV603549S RNV603781S RNV603782S RNV601797S RNV601798S RNV601879S RNV603161S RNV602387S RNV603172S RNV601651S RNV602098S RNV602260S RNV600978S RNV601167S RNV601186S RNV601716S RNV601790S RNV601804S RNV602118S RNV602126S RNV602544S RNV602641S RNV602727S RNV602740S RNV603344S RNV603586S RNV603710S RNV601348S RNV601121S RNV601132S RNV601151S RNV601657S RNV602283S RNV602776S RNV601154S RNV601377S RNV601426S RNV603642S RNV601131S RNV602135S RNV602312S RNV602515S RNV602999S RNV603570S RNV603307S RNV603728S RNV602313S RNV603525S RNV603568S RNV602093S RNV602095S RNV602882S RNV602140S RNV601058S RNV601634S RNV601675S RNV602268S RNV602490S RNV602563S RNV602611S RNV602815S RNV602949S RNV602143S RNV602110S RNV602258S RNV602979S RNV602558S RNV603252S RNV601965S RNV602296S RNV603250S RNV603178S RNV602240S RNV602793S RNV602895S RNV601354S RNV601715S RNV601913S RNV602092S RNV602566S RNV602680S RNV603308S RNV603770S RNV601347S RNV602366S RNV602226S RNV602289S RNV603083S RNV603084S RNV603404S RNV603567S RNV603640S RNV603773S RNV600968S RNV601129S RNV601462S RNV601745S RNV601784S RNV601786S RNV602012S RNV602193S RNV602391S RNV602939S RNV603216S RNV601037S RNV601376S RNV601382S RNV601389S RNV601390S RNV601717S RNV601718S RNV601719S RNV601720S RNV601749S RNV601750S RNV601755S RNV601756S RNV601886S RNV601887S RNV602026S RNV602172S RNV602173S RNV602176S RNV602664S RNV602665S RNV602666S RNV602667S RNV602668S RNV603377S RNV603378S RNV603379S RNV603410S RNV603411S RNV601731S RNV602565S RNV602567S RNV602572S RNV601948S RNV601969S RNV601494S RNV601184S RNV601369S RNV601378S RNV601440S RNV601459S RNV601533S RNV601534S RNV601961S RNV603022S RNV601009S RNV602096S RNV602418S RNV602457S RNV602458S RNV602649S RNV602846S RNV602847S RNV603263S RNV603360S RNV603438S RNV603439S RNV602965S RNV601011S RNV602057S RNV601614S RNV602264S RNV602652S RNV601792S RNV602235S RNV602253S RNV602884S RNV602594S RNV602604S RNV602714S RNV603200S RNV602600S RNV602689S RNV602763S RNV603046S RNV603050S RNV600981S RNV601120S RNV601285S RNV602248S RNV602405S RNV602483S RNV603121S RNV603499S RNV603784S RNV602411S RNV602487S RNV601605S RNV601606S RNV601723S RNV601724S RNV602751S RNV602752S RNV603254S RNV603293S RNV603767S RNV603785S RNV601107S RNV601108S RNV601110S RNV601111S RNV601112S RNV601435S RNV601437S RNV601929S RNV601930S RNV601933S RNV601939S RNV602019S RNV603723S RNV603724S RNV603725S RNV603726S RNV603727S RNV603795S RNV603796S RNV603797S RNV603798S RNV602917S RNV603566S RNV603484S RNV603460S RNV602073S RNV602731S RNV601006S RNV601007S RNV601015S RNV602496S RNV602524S RNV602764S RNV603030S RNV603056S RNV603162S RNV603239S RNV602981S RNV603464S RNV603037S RNV602909S RNV601287S RNV601500S RNV601957S RNV601958S RNV601162S RNV601137S RNV601164S RNV602865S RNV603459S RNV602398S RNV602509S RNV602512S RNV601127S RNV601128S RNV601547S RNV601881S RNV602054S RNV602089S RNV602234S RNV602612S RNV602613S RNV602639S RNV602640S RNV602899S RNV603144S RNV603145S RNV603243S RNV603244S RNV603660S RNV602817S RNV602915S RNV603302S RNV603152S RNV603756S RNV603358S RNV602142S RNV603337S RNV601458S RNV600980S RNV601650S RNV601284S RNV601019S RNV602968S RNV602900S RNV602945S RNV603012S RNV603592S RNV603593S RNV603594S RNV603595S RNV603596S RNV603597S RNV603598S RNV603599S RNV603600S RNV603601S RNV603602S RNV603603S RNV603604S RNV603605S RNV603606S RNV603607S RNV603608S
RNV603609S RNV603610S RNV603612S RNV603364S RNV603366S RNV603792S RNV601735S RNV601888S RNV601889S RNV601890S RNV601891S RNV602021S RNV601601S RNV602774S RNV602775S RNV602795S RNV601486S RNV602023S RNV601530S RNV602360S RNV603223S RNV600976S RNV601836S RNV602885S RNV602886S RNV602887S RNV603508S RNV600964S RNV601281S RNV601282S RNV601295S RNV601296S RNV601628S RNV601629S RNV601630S RNV602188S RNV602189S RNV602190S RNV602191S RNV602192S RNV602194S RNV602195S RNV602196S RNV602197S RNV602198S RNV602200S RNV602201S RNV602202S RNV602203S RNV602204S RNV602205S RNV602206S RNV602207S RNV602208S RNV602209S RNV602210S RNV602211S RNV602212S RNV601197S RNV601198S RNV601202S RNV601738S RNV602892S RNV602903S RNV603196S RNV603248S RNV601030S RNV601262S RNV601488S RNV602919S RNV601734S RNV601626S RNV601028S (b) 00643169891531 Serial Numbers: RNV602147S RNV600396S RNV600708S RNV600743S RNV600744S RNV600486S RNV601071S RNV600420S RNV600386S RNV600392S RNV600824S RNV600382S RNV600384S RNV600375S RNV600650S RNV600175S RNV600656S RNV600385S RNV600402S RNV600411S RNV600719S RNV600844S RNV600393S RNV600741S RNV600400S RNV600378S RNV600379S RNV600380S RNV600397S RNV600399S RNV600387S RNV600649S RNV600681S RNV600549S RNV600467S RNV600579S RNV600597S RNV600598S RNV600716S RNV600717S RNV600810S RNV600811S RNV600812S RNV601078S RNV600608S RNV600461S RNV600462S RNV600547S RNV600936S RNV600937S RNV600060S RNV600404S RNV600406S RNV600487S RNV600529S RNV600632S RNV600648S RNV600692S RNV600751S RNV600846S RNV600583S RNV600584S RNV600585S RNV600808S RNV600814S RNV600817S RNV600818S RNV600819S RNV601061S RNV600321S RNV600443S RNV600689S RNV600693S RNV600754S RNV600748S RNV600823S RNV600543S RNV600544S RNV600570S RNV600571S RNV600509S RNV600595S RNV601086S RNV601088S RNV600410S RNV600441S RNV600558S RNV600559S RNV600740S RNV600845S RNV600469S RNV600471S RNV600472S RNV600473S RNV600476S RNV600477S RNV600478S RNV600479S RNV600480S RNV600481S RNV600482S RNV600484S RNV600834S RNV600838S RNV600935S RNV600407S RNV600408S RNV600409S RNV600489S RNV600581S RNV600605S RNV600643S RNV600644S RNV600956S RNV600957S RNV600651S RNV600652S RNV600732S RNV600733S RNV600734S RNV600736S RNV600377S RNV600709S RNV600710S RNV600711S RNV600763S RNV600802S RNV600803S RNV600338S RNV600633S RNV600671S RNV600728S RNV600746S RNV600747S RNV600948S RNV600949S RNV600950S RNV600951S RNV600952S RNV600953S RNV600954S RNV600955S RNV600433S RNV600758S RNV600820S RNV600835S RNV600590S RNV600591S RNV600755S RNV600414S RNV600415S RNV600416S RNV600417S RNV600418S RNV600938S RNV600939S RNV601075S RNV600658S RNV600830S RNV600941S RNV600942S RNV600943S RNV600449S RNV600607S RNV600537S RNV600538S RNV600539S RNV600540S RNV600541S RNV600562S RNV600563S RNV600565S RNV600566S RNV600568S RNV600572S RNV600573S RNV600575S RNV600576S RNV600577S RNV600921S RNV600839S RNV600842S RNV600569S RNV601079S RNV601080S RNV601081S RNV600225S RNV600645S RNV601091S RNV600438S RNV600578S RNV600599S RNV600426S RNV600427S RNV600429S RNV600430S RNV600431S RNV600432S RNV601090S RNV601092S RNV601093S RNV601094S RNV601095S RNV601096S RNV601097S RNV601098S RNV601099S RNV600553S RNV600554S RNV600752S RNV600760S RNV601083S RNV601100S RNV600655S RNV600376S RNV600806S RNV600847S RNV600600S RNV600625S RNV600639S RNV600395S RNV600660S RNV600493S RNV600631S RNV600637S RNV600712S RNV600621S RNV601067S RNV600451S RNV600641S RNV601085S RNV600444S RNV600545S RNV600388S RNV600446S RNV600761S RNV601084S RNV600342S RNV600542S RNV600615S RNV600616S RNV600618S RNV600620S RNV600622S RNV600745S RNV600829S RNV600459S RNV600463S RNV600464S RNV600517S RNV600713S RNV600362S RNV600465S RNV600944S RNV600454S RNV600560S RNV600821S RNV600822S RNV600841S RNV600827S RNV600836S RNV600837S RNV600602S RNV600604S RNV600582S RNV601065S RNV601066S RNV601073S RNV600401S RNV600508S RNV600556S RNV600676S RNV600730S RNV600352S RNV600353S RNV600924S RNV600925S RNV600926S RNV600927S RNV600928S RNV600929S RNV600930S RNV600931S RNV600932S RNV600933S RNV600805S RNV600519S RNV600642S RNV600697S RNV600729S RNV600757S RNV601089S RNV600485S RNV600358S RNV600490S RNV600923S RNV600947S RNV600623S RNV600624S RNV600419S RNV600424S RNV600678S RNV600679S RNV600832S RNV600345S RNV600738S RNV600466S RNV600735S RNV600491S RNV600413S RNV600672S RNV600673S RNV600946S RNV600468S RNV600546S RNV600628S RNV600630S RNV601064S RNV600550S RNV600551S RNV600552S RNV600739S RNV600749S RNV601087S RNV600657S RNV600659S RNV600661S RNV600664S RNV600665S RNV600666S RNV600667S RNV600668S RNV600669S RNV600670S RNV600843S RNV601068S RNV600609S RNV600610S RNV600611S RNV600612S RNV600613S RNV600762S RNV600653S RNV600714S RNV600580S RNV600589S RNV600922S RNV601074S RNV600848S RNV600850S RNV600683S RNV600684S RNV600685S RNV601072S RNV600425S RNV600447S RNV600450S RNV600452S RNV600453S RNV600520S RNV600521S RNV600522S RNV600523S RNV600524S RNV600525S RNV600526S RNV600527S RNV600528S RNV600530S RNV600531S RNV600532S RNV600534S RNV600535S RNV600536S RNV600647S RNV600654S RNV600603S RNV600687S RNV600383S RNV600675S RNV600627S RNV600435S RNV600436S RNV600533S RNV600826S RNV600940S RNV600511S RNV600638S RNV600813S RNV600371S RNV600750S RNV601076S RNV600349S RNV600588S RNV600677S RNV600960S RNV601070S RNV600945S RNV600557S RNV600586S RNV600680S RNV600682S RNV600636S RNV600403S RNV600686S RNV600807S RNV600958S RNV600959S RNV600690S RNV600833S RNV601062S RNV600548S RNV600183S RNV600389S RNV600390S RNV600391S RNV600606S RNV600592S RNV600593S RNV600742S RNV601063S RNV600316S RNV600825S RNV600934S RNV600849S RNV600596S RNV600626S RNV600634S RNV600448S RNV600510S RNV600457S RNV600458S RNV600691S RNV600715S RNV601069S RNV600828S RNV600437S RNV601077S RNV600561S RNV600688S RNV600720S RNV600721S RNV600722S RNV600723S RNV600724S RNV600725S RNV600726S RNV600727S RNV600646S RNV600374S RNV600492S RNV600494S RNV600495S RNV600496S RNV600497S RNV600498S RNV600499S RNV600500S RNV600501S RNV600502S RNV600503S RNV600504S RNV600505S RNV600506S RNV600507S RNV600514S RNV600515S RNV600516S RNV600518S RNV600731S RNV600831S RNV600759S RNV600804S RNV600694S RNV600695S RNV600809S RNV600816S RNV600512S RNV600513S RNV600442S RNV600698S RNV600699S RNV600700S RNV600701S RNV600702S RNV600703S RNV600704S RNV600705S RNV600706S RNV600707S RNV600594S |
Recalling Firm/ Manufacturer |
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 8200 Coral Sea St Ne Mounds View MN 55112-4391
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For Additional Information Contact | Medtronic Technical Services 800-723-4636 |
Manufacturer Reason for Recall | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP). |
FDA Determined Cause 2 | Device Design |
Action | On 21-Jun-2018, Medtronic began notifying US physicians and health care professionals of this issue and provided Patient Management recommendations to ensure patient safety.
A Software Update to SW040 Version 8.1 will be deployed to all Medtronic 2090 and Encore clinic and hospital programmers via the Software Distribution Network or USB. Field Representatives with customers who have Percepta CRT-P patients will be sent a USB device loaded with the updated software.
In consultation with an Independent Physician Quality Panel, Medtronic recommends the following actions for physicians following patients:
- Contact your local Medtronic Representative and schedule installation of the updated Percepta CRT-P Application Software (SW040 Version 8.1) onto Medtronic 2090 and Encore clinic and hospital programmers.
- For a patient whose Percepta CRT-P device has experienced a Reset Alert or Observation: Consider scheduling an in-clinic device interrogation as soon as possible for the patients device to receive the automatic update.
- For a patient whose Percepta CRT-P device has not experienced a Reset Alert or Observation: At their next scheduled in-clinic device interrogation, the patients device will receive the automatic update.
Please complete the enclosed Clinician Confirmation Certificate and return via email to RS.CFQFCA@medtronic.com.
For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636. |
Quantity in Commerce | 3560 units |
Distribution | Worldwide Distribution - US Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = NKE
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