Manufacturers

EndoChoice, Inc.

  • 제조사 주소
    EndoChoice, Inc., 11810 Wills Rd Ste 100, ATTN: Theron Gober, Alpharetta GA 30009-2081
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA
  • 1 Event

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 1 건

Device Recall Fuse 1C Colonoscope
  • 모델명 / 제조번호(시리얼번호)
    Item number: FSC-3300-SL, Model number: C38s, Serial numbers: F1C0218FUSE1CS, F1C0219FUSE1CS, F1C0220FUSE1CS, F1C0221FUSE1CS, F1C0222FUSE1CS, F1C0223FUSE1CS, F1C0224FUSE1CS, F1C0225FUSE1CS, F1C0228FUSE1CS, F1C0229FUSE1CS, F1C0230FUSE1CS, F1C0231FUSE1CS, F1C0232FUSE1CS, F1C0233FUSE1CS, F1C0235FUSE1CS, F1C0236FUSE1CS, F1C0237FUSE1CS, F1C0238FUSE1CS, F1C0239FUSE1CS, F1C0241FUSE1CS, F1C0243FUSE1CS, F1C0245FUSE1CS, F1C0246FUSE1CS, F1C0247FUSE1CS, F1C0248FUSE1CS, F1C0249FUSE1CS, F1C0250FUSE1CS, F1C0251FUSE1CS, F1C0252FUSE1CS, F1C0253FUSE1CS, F1C0254FUSE1CS, F1C0255FUSE1CS, F1C0256FUSE1CS, F1C0257FUSE1CS, F1C0258FUSE1CS, F1C0259FUSE1CS, F1C0261FUSE1CS, F1C0262FUSE1CS, F1C0263FUSE1CS, F1C0264FUSE1CS, F1C0266FUSE1CS, F1C0267FUSE1CS, F1C0268FUSE1CS, F1C0269FUSE1CS, F1C0270FUSE1CS, F1C0271FUSE1CS, F1C0272FUSE1CS, F1C0273FUSE1CS, F1C0274FUSE1CS, F1C0276FUSE1CS, F1C0277FUSE1CS, F1C0278FUSE1CS, F1C0279FUSE1CS, F1C0280FUSE1CS, F1C0281FUSE1CS, F1C0282FUSE1CS, F1C0284FUSE1CS,  F1C0285FUSE1CS, F1C0287FUSE1CS, F1C0288FUSE1CS, F1C0289FUSE1CS, F1C0290FUSE1CS, F1C0291FUSE1CS, F1C0292FUSE1CS, F1C0293FUSE1CS, F1C0294FUSE1CS, F1C0296FUSE1CS, F1C0297FUSE1CS, F1C0298FUSE1CS, F1C0299FUSE1CS, F1C0300FUSE1CS, F1C0301FUSE1CS, F1C0305FUSE1CS ; Item number: FSC-330-C6333, Model number: C38s-150, Serial numbers: 0600200, 0600201, 0600202, 0600203, 0600204, 0600205 and 0600206; Item number: FSC-3300-ST, Model number: F1C, Serial numbers: F1C0214FUSE1C-150F1C0241FUSEC1, F1C0244FUSE1C-A, F1C0244FUSEC1, F1C0255FUSE1C-A, F1C0259FUSE1C, F1C0271FUSE1C, F1C0283FUSE1C, F1C0312FUSE1C, F1C0313FUSE1C, F1C0322FUSE1C, F1C0334FUSE1C, F1C0356FUSE1C, F1C0382FUSE1C, F1C0388FUSE1C, F1C0425FUSE1C, F1C0433FUSE1C, F1C0437FUSE1C, F1C0447FUSE1C, F1C0449FUSE1C, F1C0458FUSE1C, F1C0461FUSE1C, F1C0475FUSE1C, F1C0479FUSE1C, F1C0484FUSE1C, F1C0488FUSE1C, F1C0489FUSE1C, F1C0516FUSE1C, F1C0526FUSE1C, F1C0530FUSE1C, F1C0531FUSE1C, F1C0536FUSE1C, F1C0537FUSE1C, F1C0540FUSE1C, F1C0542FUSE1C, F1C0543FUSE1C, F1C0544FUSE1C, F1C0545FUSE1C, F1C0546FUSE1C, F1C0547FUSE1C, F1C0549FUSE1C, F1C0584FUSE1C, F1C0586FUSE1C, F1C0603FUSE1C, F1C0640FUSE1C, F1C0660FUSE1C, F1C0668FUSE1C, F1C0691FUSE1C, F1C0692FUSE1C, F1C0693FUSE1C, F1C0694FUSE1C, F1C0709FUSE1C, F1C0714FUSE1C, F1C0736FUSE1C, F1C0739FUSE1C, F1C0742FUSE1C, F1C0745FUSE1C, F1C0749FUSE1C, F1C0758FUSE1C, F1C0763FUSE1C, F1C0765FUSE1C, F1C0767FUSE1C, F1C0776FUSE1C, F1C0778FUSE1C, F1C0779FUSE1C, F1C0786FUSE1C, F1C0790FUSE1CL, F1C0791FUSE1CL, F1C0794FUSE1C, F1C0796FUSE1C, F1C0799FUSE1C, F1C0800FUSE1CL, F1C0802FUSE1C, F1C0806FUSE1C, F1C0811FUSE1C, F1C0812FUSE1C, F1C0814FUSE1C, F1C0817FUSE1C, F1C0818FUSE1C, F1C0825FUSE1C, F1C0827FUSE1C, F1C0828FUSE1C, F1C0829FUSE1C, F1C0831FUSE1C, F1C0833FUSE1C, F1C0834FUSE1C, F1C0835FUSE1C, F1C0837FUSE1C, F1C0838FUSE1C, F1C0841FUSE1C, F1C0849FUSE1C, F1C0852FUSE1C, F1C0857FUSE1C, F1C0858FUSE1C, F1C0859FUSE1C, F1C0860FUSE1C, F1C0862FUSE1C, F1C0863FUSE1C, F1C0864FUSE1C, F1C0866FUSE1C, F1C0867FUSE1C, F1C0868FUSE1C, F1C0870FUSE1C, F1C0871FUSE1C, F1C0872FUSE1C, F1C0873FUSE1C, F1C0874FUSE1C, F1C0875FUSE1C, F1C0876FUSE1C, F1C0878FUSE1C, F1C0879FUSE1C, F1C0880FUSE1C, F1C0883FUSE1C, F1C0884FUSE1C, F1C0885FUSE1C, F1C0893FUSE1C, F1C0894FUSE1C, F1C0895FUSE1C, F1C0898FUSE1C, F1C0900FUSE1C, F1C0902FUSE1C, F1C0905FUSE1C, F1C0906FUSE1C, F1C0907FUSE1C, F1C0908FUSE1C, F1C0910FUSE1C F1C0921FUSE1C; Item number: FSC330-A6334, Model number: F1C-MC90, Serial numbers: 0700200, 0700204, 0700205, 0700207, 0700209, 0700210, 0700212, 0700215 and 0700217; Item number: FDC-3300-133, Model number: Fuse Colo 133, Serial numbers: F1C0201FUSE1C-133, F1C0202FUSE1C-133, F1C0203FUSE1C-133, F1C0204FUSE-133, F1C0205FUSE1C-133, F1C0206FUSE1C-133, F1C0207FUSE1C-133, F1C0208FUSE1C-133, F1C0209FUSE1C-133, F1C0210FUSE1C-133, F1C0211FUSE1C-133, F1C0216FUSE1C-133, F1C0217FUSE1C-133, F1C0218FUSE1C-133, F1C0219FUSE1C-133, F1C0221FUSE1C-133, F1C0222FUSE1C-133, F1C0223FUSE1C-133, F1C0224FUSE1C-133. F1C0225FUSE1C-133, F1C0226FUSE1C-133, F1C0227FUSE1C-133, F1C0228FUSE1C-133, F1C0229FUSE1C-133, F1C0230FUSE1C-133, F1C0235FUSE1C-133 and Item number: FSC-3300-150, Model number: Fuse Colo 150, Serial numbers: F1C0202FUSE1C-150, F1C0203FUSE1C-150, F1C0204FUSE1C-150, F1C0205FUSE1C-150, F1C0206FUSE1C-150, F1C0207FUSE1C-150, F1C0208FUSE1C-150, F1C0209FUSE1C-150, F1C0210FUSE1C-150, F1C0211FUSE1C-150, F1C0212FUSE1C-150, F1C0214FUSE1C-150.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.
  • 제품 설명
    Fuse 1C Colonoscope

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

EndoChoice, Inc.
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DMA