Events

Rappel de ORCHESTRA and ORCHESTRA PLUS Programmers

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Sorin Group USA, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75456
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0412-2017
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150425
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Programmer, pacemaker - Product Code KRG
  • Cause
    Sorin group usa, inc. announces a voluntary field action for the orchestra programmer and orchestra plus programmer because the residual longevity estimate may be less accurate.
  • Action
    The firm, LivaNova, sent an "Urgent Field Safety Notice" dated 9/29/2016 to its customers. The notice described the product, problem, actions to be taken. The notice states that a Sorin representative will contact customers to upgrade the software in the facility's programmer. If customers have any questions, they are urged to call their LivaNova representative or contact LivaNova Technical Services at 877.663.7674.

Device

ORCHESTRA and ORCHESTRA PLUS Programmers
  • Modèle / numéro de série
    Serial Numbers: BB0011103G BC0206105G BC0408064G BB0011111G BD0505094I BC0405016G BB0102071G BC0206096G BD0507033I BD0505110I BD0507019I BC0206076G BE0611036I BB0203034G BB0011099G BB0103048G BC0408067G BD0509044I BB0012010G BD0501100G BC0206131G BD0501096G BA0006167G BB0011169G BD0510018I BD0505029I BD0505039I BB0102074G BD0507014I BB0101021G BD0506112I BA0007003G BB0010078G BB0010213G BC0206089G BC0205079G BD0501099G BA0004162G BB0011101G BD0501094G BB0103027G BB0012068G BD0507005I BB0011003G BB0011086G BC0408057G BB0012075G BA0005050G BC0303071G BD0507060I BB0010268G BB0012154G BC0303073G BA0006171G BB0011080G BC0312045G BC0206144G BD0505016I BC0206029G BB0012184G BD0505018I BC0405050G BD0501085G BD0506136I BB0011083G BB0012056G BE0611013I BD0507053I BD0505028I BC0408078G BE0603002I BE0603012I BB0011166G BB0012150G BB0012067G BB0012171G BB0011020G BC0212074G BB0010250G BD0507025I BB0203012G BD0501061G BC0206110G BE0611023I BB0011141G BD0502041G BE0611087I BB0012017G BB0010193G 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BC0405035G BB0010208G BC0408074G BC0206106G BD0510030I BB0012165G BC0303075G BD0506114I BD0502010G BC0303081G BB0011159G BB0010229G BB0011163G BD0507011I BE0611051I BE0611040I BC0405044G BB0012082G BB0012124G BC0206019G BD0502014G BB0011171G BB0010251G BC0206032G BD0507017I BC0205070G BB0111033G BE0603013I BE0603008I BB0012015G BA0006185G BC0205061G BB0103060G BB0103067G BC0408055G BD0502009G BB0011175G BD0505017I BD0505064I BD0501083G BB0010221G BD0506128I BC0206114G BD0505021I BB0102019G BC0312050G BC0212090G BE0611075I BC0206040G BD0507003I BC0206066G BB0012126G BD0506100I BE0611060I BD0507075I BD0510032I BE0611027I BB0011100G BD0507074I BE0611017I BC0206035G BB0203005G BC0312061G BB0102066G BC0212051GCS = "Case Sensitive"BB0011103G BC0206105G BC0408064G BB0011111G BD0505094I BC0405016G BB0102071G BC0206096G BD0507033I BD0505110I BD0507019I BC0206076G BE0611036I BB0203034G BB0011099G BB0103048G BC0408067G BD0509044I BB0012010G BD0501100G BC0206131G BD0501096G BA0006167G BB0011169G 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BB0012019G BB0203028G BB0012062G BB0010057G BC0212080G BE0603018I BC0312059G BE0611082I BC0405025G BC0206067G BB0010273G BB0102068G BB0011032G BB0010080G BB0010271G BA0005233G BD0506111I BD0502035G BD0509046I BC0206138G BD0505002I BB0012166G BC0408072G BD0506106I BE0611041I BE0611043I BA0004161G BB0011037G BB0203037G BD0505045I BD0505052I BD0505008I BB0010294G BB0011042G BB0012070G BD0501118G BD0501116G BE0611008I BC0212068G BC0212083G BD0501109G BB0012027G BB0010207G BC0212085G BC0212086G BD0501087G BB0203050G BB0010291G BC0212079G BE0611022I BE0611009I BB0012060G BD0510024I BD0505068I BD0510022I BD0506125I BC0212048G BD0505090I BB0102059G BC0312055G BC0206146G BC0206073G BD0506124I BC0303082G BB0102075G BC0408075G BC0405047G BD0505106I BB0012131G BC0212046G BC0312066G BC0205068G BC0405052G BB0012004G BB0012013G BC0312049G BD0501066G BD0507063I BB0012063G BC0206083G BD0501092G BC0206075G BC0405023G BB0012012G BD0501071G BB0012074G BC0206071G BB0101023G BD0505053I BD0502003G BD0506101I BD0507061I BC0408052G BB0103059G BC0205089G BC0206046G BD0505080I BD0510009I BB0012160G BC0206134G BD0501081G BA0005349G BB0012146G BC0312044G BB0011120G BB0010215G BC0206027G BB0011180G BB0010082G BB0011170G BB0010297G BD0507038I BD0505077I BB0012001G BB0101020G BB0012176G BD0505074I BB0012143G BB0012141G BD0505107I BD0505033I BD0502038G BB0011036G BC0206016G BD0506103I BC0405064G BB0203046G BC0206080G BB0203020G BB0012023G BC0405045G BD0506143I BD0505040I BD0506144I BB0203018G BC0312068G BD0507069I BB0103074G BD0501075G BB0010052G BE0611069I BB0010076G BA0006181G BD0505050I BB0011105G BC0405049G BB0012008G BB0101083G BD0502031G BD0507020I BB0010216G BC0206154G BD0506098I BE0611048I BB0103022G BB0010222G BD0505048I BE0611063I BA0006183G BD0501070G BC0405006G BD0507001I BB0012181G BB0012022G BC0206042G BB0103041G BB0010254G BC0312069G BB0010269G BD0507043I BB0103047G BB0011046G BE0611024I BD0506099I BC0212061G BB0012162G BB0011081G BD0506117I BB0203013G BD0507024I BB0012158G BD0505044I BE0603014I BB0012071G BC0206116G BC0206109G BD0505066I BC0212081G BD0510014I BE0611005I BD0506110I BC0206102G BB0012002G BC0405053G BB0103039G BB0011165G BA0006179G BB0103058G BB0012119G BB0103046G BD0505036I BD0506109I BE0611073I BD0501078G BB0010285G BC0206100G BB0012018G BD0502042G BD0505101I BC0206149G BC0303090G BC0205086G BD0505085I BB0012024G BB0010105G BB0010183G BB0010051G BB0011164G BD0507044I BC0212062G BB0102077G BC0206079G BB0011038G BB0010230G BC0206018G BB0010284G BB0010049G BC0212056G BC0205071G BD0501107G BB0203011G BD0505089I BB0203022G BE0611076I BB0102064G BB0203057G BB0203041G BB0011108G BD0510020I BC0205087G BD0510031I BD0507010I BC0212078G BD0505072I BC0206148G BC0206099G BB0010241G BA0004165G BB0203035G BB0010289G BB0010184G BB0103062G BB0103043G BD0506097I BD0501089G BD0509049I BB0012136G BB0012133G BC0206098G BE0611016I BD0507057I BD0502002G BB0010214G BD0505030I BD0502015G BB0011112G BD0505047I BC0205077G BB0012135G BD0507034I BC0405005G BB0010061G BE0611021I BB0010264G BD0505058I BB0012145G BC0205062G BB0012116G BA0007063G BE0611033I BC0408069G BC0206062G BB0010279G BD0505038I BC0303080G BB0010293G BB0203044G BB0011161G BD0507058I BD0505065I BD0507002I BB0010283G BC0405032G BC0206033G BE0611006I BB0012113G BA0006170G BC0206153G BE0611070I BD0502008G BB0011102G BD0507046I BD0505042I BC0405048G BE0611010I BC0206072G BC0205074G BD0507035I BB0011104G BD0505009I BC0405008G BC0206141G BB0011118G BB0011040G BB0012132G BB0010060G BD0506121I BC0206145G BD0507072I BC0408058G BB0010071G BB0012134G BB0012033G BE0611079I BC0312053G BB0011116G BC0206024G BB0102067G BE0611011I BB0101087G BC0212088G BC0212084G BD0507062I BD0502025G BD0510017I BE0611019I BB0012085G BB0012086G BC0408066G BD0507064I BB0012200G BB0011092G BD0507031I BB0101080G BC0408073G BC0405039G BC0212087G BB0012079G BD0501064G BB0203002G BB0103038G BD0502012G BB0012054G BD0501091G BA0006174G BC0303076G BB0012155G BB0012026G BE0611030I BD0505087I BC0206107G BC0405013G BC0405028G BD0502027G BB0011029G BE0611029I BB0012163G BC0206155G BB0101027G BC0206133G BC0303088G BB0012003G BE0611046I BC0405065G BD0505049I BD0501093G BD0501108G BB0012114G BB0010242G BC0405021G BB0102060G BB0011126G BB0010062G BB0012185G BD0506093I BD0502022G BE0611028I BB0010238G BB0010070G BB0010265G BC0405062G BB0012078G BD0502006G BB0203043G BD0506091I BB0011026G BD0501068G BD0510007I BC0206115G BC0312067G BB0010256G BC0405043G BB0010288G BB0011137G BD0507039I BE0611047I BD0505067I BD0501110G BD0505041I BB0101081G BB0103052G BD0507049I BD0507013I BB0012120G BB0010075G BC0405066G BB0102062G BE0603011I BE0611003I BD0502043G BB0011167G BB0011158G BC0206081G BB0010185G BA0004159G BC0405009G BE0611015I BC0303089G BB0011131G BC0408079G BD0502024G BD0502016G BB0011002G BB0103069G BB0103024G BB0012115G BD0501082G BB0101084G BD0510016I BD0505104I BD0505019I BD0505051I BB0103061G BD0505086I BC0303086G BB0012186G BB0012178G BD0501101G BC0405042G BB0011157G BB0010206G BC0206093G BC0405067G BB0011090G BC0405030G BC0206031G BB0012180G BD0510023I BC0206152G BD0505105I BD0501095G BD0502040G BB0012011G BB0010068G BB0010300G BD0501111G BB0011179G BC0206150G BB0012077G BB0011095G BD0505079I BB0012036G BB0203008G BC0212071G BC0312046G BC0206103G BB0010190G BD0505096I BE0611018I BB0203054G BC0405020G BD0506129I BB0010224G BC0206077G BD0505059I BD0507056I BB0010228G BB0011138G BC0206151G BB0010217G BB0010239G BB0011098G BB0012159G BD0505037I BB0010245G BC0206088G BD0507073I BA0006098G BC0206091G BE0603010I BC0206125G BC0405033G BD0510013I BB0012127G BD0507036I BB0010210G BC0206084G BC0405012G BB0012081G BE0611044I BE0611050I BB0102070G BB0102079G BE0611014I BD0507030I BC0312042G BD0506127I BC0205093G BD0501073G BB0012111G BD0506126I BC0212082G BD0502034G BD0506108I BA0006175G BC0405011G BE0611002I BA0005347G BC0206143G BB0012149G BC0303087G BB0011034G BB0203029G BB0103056G BC0405040G BC0312060G BD0502029G BD0507071I BC0206044G BC0312063G BC0206119G BD0510029I BC0312065G BD0501090G BD0507070I BD0501088G BE0611080I BD0505012I BB0010081G BB0203047G BD0506137I BB0103064G BA0006100G BB0010253G BB0102021G BB0102082G BB0012059G BB0011134G BD0507041I BE0611012I BD0505083I BC0405059G BC0206104G BD0501117G BD0506142I BB0012053G BB0012069G BC0205076G BD0507029I BE0603005I BB0011121G BC0408071G BD0505007I BC0205091G BD0507022I BB0011156G BC0212055G BB0011144G BC0205069G BB0010182G BC0312054G BB0010189G BB0010275G BB0010259G BB0203048G BB0012021G BD0502004G BC0206057G BD0501084G BB0102065G BD0502018G BD0505022I BC0206069G BD0505082I BC0206043G BD0506130I BE0611032I BB0011024G BE0611034I BC0405001G BC0206142G BD0506113I BD0507015I BD0502037G BB0011001G BB0010225G BC0408060G BB0010281G BB0111034G BD0509045I BB0012080G BD0501104G BB0103042G BD0505015I BB0011114G BB0010258G BD0505011I BD0501065G BE0603007I BB0012061G BD0507004I BB0012157G BE0611059I BC0206092G BB0103050G BB0011110G BE0611026I BB0010108G BC0212064G BC0205078G BA0007064G BB0011021G BD0505035I BB0012179G BD0507037I BD0510005I BE0611038I BB0010074G BC0206124G BD0507076I BC0212077G BB0102080G BC0206021G BB0103036G BC0405041G BD0502039G BB0103035G BB0010255G BD0506105I BB0103028G BB0102081G BC0206122G BA0007001G BD0505081I BD0506095I BB0010218G BC0405056G BD0505100I BE0611020I BB0011109G BB0012137G BC0212066G BB0010110G BC0312058G BB0011087G BC0405017G BC0206053G BC0405035G BB0010208G BC0408074G BC0206106G BD0510030I BB0012165G BC0303075G BD0506114I BD0502010G BC0303081G BB0011159G BB0010229G BB0011163G BD0507011I BE0611051I BE0611040I BC0405044G BB0012082G BB0012124G BC0206019G BD0502014G BB0011171G BB0010251G BC0206032G BD0507017I BC0205070G BB0111033G BE0603013I BE0603008I BB0012015G BA0006185G BC0205061G BB0103060G BB0103067G BC0408055G BD0502009G BB0011175G BD0505017I BD0505064I BD0501083G BB0010221G BD0506128I BC0206114G BD0505021I BB0102019G BC0312050G BC0212090G BE0611075I BC0206040G BD0507003I BC0206066G BB0012126G BD0506100I BE0611060I BD0507075I BD0510032I BE0611027I BB0011100G BD0507074I BE0611017I BC0206035G BB0203005G BC0312061G BB0102066G BC0212051G
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
  • Description du dispositif
    The ORCHESTRA Programmer || A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant || patients.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Adresse du fabricant
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA