Events

ORCHESTRA PLUS Programmer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sorin Group USA, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    75456
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0413-2017
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150426
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Programmer, pacemaker - Product Code KRG
  • 원인
    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.
  • 조치
    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 PLUS Programmer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: NB1006418K NB1107409K NB1203456K NB1107407K NB1105419K NB0908405K NB1202447K NA0804365K NB1201447K NA0807425K NB0909407K NB1112470K NB0909402K NB1112474K NB1112444K NB1201403K NB1201402K NB1102423K NB1112471K NA0804393K NB1203431K NA0804389K NB1004403K NB1202418K NB1108403K NB1007410K NB1105438K NA0804367K NB1102406K NA0804384K NB1202458K NA0804321K NB1006415K NB1201455K NB1102402K NB1107417K NB1109421K NB1202454K NC1503413K NA0804353K NB1112482K NB1108404K NB1105436K NB0907430K NB1112485K NA0804343K NB1109418K NB1104409K NB1112414K NB0908415K NB1112407K NB1108425K NB1006402K NB1203428K NA0804426K NA0804390K NB0911402K NB0907419K NB0909417K NB1203415K NB1201442K NA0804363K NB0911414K NB0908411K NB0910412K NA0807414K NA0804387K NB1102405K NB1201409K NB1201423K NB1004416K NB1108401K NB1002406K NB1203429K NB0907433K NB1202474K NB1103415K NB1112427K NB1202462K NB1202469K NA0804319K NB1102425K NA0804339K NB1003402K NB1102404K NB0909410K NB0911404K NB1108429K NB1203444K NB1203423K NB1201434K NA0804410K NB0909430K NB1202413K NB1201454K NB1001405K NA0904419K NA0902423K NB0907425K NB1202435K NB1203417K NA0904415K NB0907413K NB1105401K NB1112455K NA0904413K NB1112423K NB1201410K NB1112404K NA0904414K NB1108428K NB1112454K NB0911401K NB1007406K NB1102428K NB1201450K NB1001409K NB1112463K NA0804433K NB1105404K NB1202423K NB1201430K NB1203453K NB1006410K NC1503412K NA0804373K NA0804378K NB1201449K NA0804358K NB1108412K NB1201406K NB0907410K NB1006403K NA0804362K NB1004406K NB0908414K NA0902406K NA0804432K NB1002401K NB0909405K NA0807429K NB0911415K NA0804313K NB1109402K NB1203454K NB1202409K NB1202453K NB1201440K NB0905015K NB1202464K NB1202442K NA0804340K NB1201439K NB1109412K NB1102407K NB1112410K NB1108418K NB1104416K NB0907414K NB1202424K NB1201445K NB1201452K NB0907417K NB1202432K NA0804411K NB1202408K NB1007402K NB1103409K NB1112459K NB1202430K NA0804383K NB1108426K NB1010412K NB0911412K NB1202440K NB1102429K NB1104405K NB1203409K NB1010408K NB1109417K NB1108410K NB1203437K NA0804324K NA0804422K NB0905017K NB1108424K NB1007412K NB1112442K NB1112438K NB1112460K NB1108422K NB1006404K NB1104406K NB1007407K NA0904416K NB1107408K NB1104413K NB1202439K NA0804391K NB1105429K NB1107401K NB1006401K NB0907409K NB1003406K NB1109420K NB1112443K NB1102411K NA0804309K NB1108416K NB1203421K NB1102419K NB1202420K NA0804323K NA0804352K NB1202438K NB1202444K NB1006405K NB1004414K NB1202459K NC1503404K NB1107414K NB1108419K NB1108423K NC1503407K NB1108409K NA0804336K NA0804341K NA0804305K NB1108432K NB1112461K NB1007404K NB1112453K NB1109416K NA0804386K NC1503408K NB0907408K NB1102415K NB1001404K NB1112420K NA0804306K NB0908417K NA0902401K NB1203402K NB0909406K NB1004404K NB0907427K NB1203451K NA0804320K NA0807424K NB1201435K NB1109422K NB0910413K NB1202477K NB1203401K NB1203452K NA0804394K NA0902422K NA0804329K NB1109414K NB1201460K NB1104404K NB1003403K NB1203448K NB0907422K NB1105431K NB1004410K NB0909401K NB1201401K NB1112475K NC1503401K NB1108406K NB1201424K NA0807416K NB1105417K NB1105422K NB0909414K NB0908420K NB1112426K NB0908401K NB1107412K NB1202467K NB1004407K NB1010413K NB1004412K NB1003405K NB1112403K NA0807415K NB1202450K NB1103407K NB1104410K NB1104411K NB1202451K NA0904408K NB1112473K NB1202473K NB1202456K NB1109407K NB0908402K NB1202468K NA0804356K NB1003404K NA0804308K NA0804359K NA0804370K NB1203441K NB1203442K NB1103417K NB1103419K NB1007411K NA0804334K NB1105406K NB1109424K NC1503414K NB1105428K NA0902411K NB1201429K NB0910414K NB1102412K NB1103412K NB0911403K NB1112434K NC1503409K NA0804409K NB0905018K NB1104402K NA0804330K NB1112448K NB1201407K NB1203411K NA0804396K NB1202436K NB0907431K NB1102409K NB1006419K NB1006409K NB1007401K NB1109419K NB1203419K NB1105403K NB1203426K NB1202455K NB1102422K NB1105407K NB1109405K NA0804360K NB1112457K NA0902409K NB0909420K NB1004405K NB1112417K NA0804427K NB1201417K NB1201404K NA0902407K NB1112480K NB1201427K NB1102420K NB1112484K NA0804397K NB0907412K NB1202437K NB1112424K 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NB1203417K NA0904415K NB0907413K NB1105401K NB1112455K NA0904413K NB1112423K NB1201410K NB1112404K NA0904414K NB1108428K NB1112454K NB0911401K NB1007406K NB1102428K NB1201450K NB1001409K NB1112463K NA0804433K NB1105404K NB1202423K NB1201430K NB1203453K NB1006410K NC1503412K NA0804373K NA0804378K NB1201449K NA0804358K NB1108412K NB1201406K NB0907410K NB1006403K NA0804362K NB1004406K NB0908414K NA0902406K NA0804432K NB1002401K NB0909405K NA0807429K NB0911415K NA0804313K NB1109402K NB1203454K NB1202409K NB1202453K NB1201440K NB0905015K NB1202464K NB1202442K NA0804340K NB1201439K NB1109412K NB1102407K NB1112410K NB1108418K NB1104416K NB0907414K NB1202424K NB1201445K NB1201452K NB0907417K NB1202432K NA0804411K NB1202408K NB1007402K NB1103409K NB1112459K NB1202430K NA0804383K NB1108426K NB1010412K NB0911412K NB1202440K NB1102429K NB1104405K NB1203409K NB1010408K NB1109417K NB1108410K NB1203437K NA0804324K NA0804422K NB0905017K NB1108424K NB1007412K NB1112442K NB1112438K NB1112460K NB1108422K NB1006404K NB1104406K NB1007407K NA0904416K NB1107408K NB1104413K NB1202439K NA0804391K NB1105429K NB1107401K NB1006401K NB0907409K NB1003406K NB1109420K NB1112443K NB1102411K NA0804309K NB1108416K NB1203421K NB1102419K NB1202420K NA0804323K NA0804352K NB1202438K NB1202444K NB1006405K NB1004414K NB1202459K NC1503404K NB1107414K NB1108419K NB1108423K NC1503407K NB1108409K NA0804336K NA0804341K NA0804305K NB1108432K NB1112461K NB1007404K NB1112453K NB1109416K NA0804386K NC1503408K NB0907408K NB1102415K NB1001404K NB1112420K NA0804306K NB0908417K NA0902401K NB1203402K NB0909406K NB1004404K NB0907427K NB1203451K NA0804320K NA0807424K NB1201435K NB1109422K NB0910413K NB1202477K NB1203401K NB1203452K NA0804394K NA0902422K NA0804329K NB1109414K NB1201460K NB1104404K NB1003403K NB1203448K NB0907422K NB1105431K NB1004410K NB0909401K NB1201401K NB1112475K NC1503401K NB1108406K NB1201424K NA0807416K NB1105417K NB1105422K NB0909414K NB0908420K NB1112426K NB0908401K NB1107412K NB1202467K NB1004407K NB1010413K NB1004412K NB1003405K NB1112403K NA0807415K NB1202450K NB1103407K NB1104410K NB1104411K NB1202451K NA0904408K NB1112473K NB1202473K NB1202456K NB1109407K NB0908402K NB1202468K NA0804356K NB1003404K NA0804308K NA0804359K NA0804370K NB1203441K NB1203442K NB1103417K NB1103419K NB1007411K NA0804334K NB1105406K NB1109424K NC1503414K NB1105428K NA0902411K NB1201429K NB0910414K NB1102412K NB1103412K NB0911403K NB1112434K NC1503409K NA0804409K NB0905018K NB1104402K NA0804330K NB1112448K NB1201407K NB1203411K NA0804396K NB1202436K NB0907431K NB1102409K NB1006419K NB1006409K NB1007401K NB1109419K NB1203419K NB1105403K NB1203426K NB1202455K NB1102422K NB1105407K NB1109405K NA0804360K NB1112457K NA0902409K NB0909420K NB1004405K NB1112417K NA0804427K NB1201417K NB1201404K NA0902407K NB1112480K NB1201427K NB1102420K NB1112484K NA0804397K NB0907412K NB1202437K NB1112424K NB1104418K NB1103414K NB1010416K NB1102427K NB1202463K NB1202431K NB1102410K NB1012407K NA0804369K NB1108431K NA0807428K NB1201433K NB1112441K NB1108413K NB1201412K NB1108415K NB1108420K NB1108427K NB1010409K NB1203449K NB1112462K NA0804354K NB0905011K NB0907434K NB0907423K NB1203430K NB1202429K NA0804349K NB0907428K NB1001402K NA0902405K NB1102421K NB0910401K NB1004402K NB1112419K NB1105425K NB1201457K NA0804429K NA0804368K NA0902421K NA0804423K NB0910403K NB1007413K NB1112439K NB1201416K NB0907415K NB1202448K NA0902403K NB1202445K NB1201413K NA0804317K NB1202457K NB1104414K NB1004401K NB0908406K NB0908408K NB1104403K NA0902420K NB1112433K NB1007409K NA0804392K NB1112451K NA0904410K NB1109425K NB0910408K NB1012405K NB1105420K NB1006414K NB1104419K ND1603401K NA0804366K NB1203434K NB1109423K NB1112458K NB1203407K NB1203413K NB1203406K NA0804312K NA0804310K NB1112447K NB1112477K NB1103406K NB1202446K NB1202421K NB1102401K NB1203435K NB1112406K NB1112430K NB1107404K NB1112409K NA0804315K NA0804311K NB1112422K NA0902418K NB1203422K NB1102408K NB1202478K NB1203412K NB1203425K NB1202441K NB1006413K NB1109401K NB1201408K NB1201453K NB0907429K NB1012402K NA0904407K NB1108421K NB1105432K NB0907421K NA0804385K NB1112483K NB1103404K NB1112425K NB0911410K NB0910409K NA0804318K NB1107413K NB1004409K NA0804333K NA0807418K NB1012404K NB1201415K NB1109404K NB1105427K NB1202466K NB1103416K NB1108408K NB1202434K NB0905009K NA0804348K NB1105433K NB1202414K NB1203436K NB0908413K NA0904420K NC1503405K NB1102426K NB1203447K NB0911405K NB1201441K NB1202479K NB1010414K NB1203432K NB1012401K NB1108402K NB0905013K NB1108414K NB1203427K NB1203418K NB1201431K NB1102416K NB1103410K NA0804361K NA0904409K NB1105402K NB1105440K NB1202417K NB1112429K NB1112472K NA0705031K NB1112416K NB1112440K NB0908407K NA0902415K NB1203405K NB0908419K NB1102403K NB1112446K NB1004408K NB1010417K NB1203457K NB0909416K NB1203433K NB1201411K NB1007405K NA0807426K NB0909404K NB1102424K NB1107405K NB1107406K NB1203414K NA0804374K NB1108438K NB1109403K NB1002404K NB1103403K NB1010407K NA0804342K NB1203403K NB1112476K NB1202416K NB1010402K NB1202412K NB1203445K NB1103420K NA0804382K NB1006411K NA0804398K NB1201432K NB1203446K NB1203450K NB0907405K NB1108430K NB1109415K NB1010410K NB1010411K NB1006406K NA0902424K NA0807430K NA0902413K NB0908412K NB1004411K NB1006416K NB1201451K NB1002402K NB1103418K NB1010403K NA0807412K NB1105426K NB1202465K NB1112466K NB0909403K NB1203424K
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
  • 제품 설명
    The ORCHESTRA PLUS 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.
  • 제조사 주소
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • 제조사 모회사 (2017)
    LivaNova PLC
  • Source
    USFDA