Events

Device Recall Electrosurgical generator. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed Electrosurgery 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
    57544
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1362-2011
  • 사례 시작날짜
    2010-12-27
  • 사례 출판 날짜
    2011-02-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96492
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
  • 조치
    ConMed Electrosurgery sent an Urgent Device Recall letter dted December 27, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify anyone who may have received the affected product.. They were to review their inventory and return a Business Reply Form via fax to 303-699-9854 and to contact ConMed Electrosurgery Technical Services at 800-552-0138 to schedule a time to have their equipment upgraded.

Device

Device Recall Electrosurgical generator.
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 09AGU111, 09AGU112, 09AGU113, 09AGU114, 09AGU115, 09AGU116, 08FGU100, 08FGU101, 08FGU102, 08FGU103, 08FGU104, 08FGU105, 08FGU106, 08FGU107, 08FGU108, 08FGU109, 08GGU001, 08GGU002, 08GGU003, 08GGU004, 08GGU005, 08GGU006, 08GGU007, 08GGU008, 08GGU009, 08GGU010, 08GGU011, 08GGU012, 08GGU013, 08GGU014, 08GGU015, 08GGU016, 08GGU017, 08GGU018, 08GGU019, 08GGU020, 08GGU021, 08GGU022, 08GGU023, 08GGU024, 08GGU025, 08GGU026, 08GGU027, 08GGU028, 08KGU071, 08KGU072, 08KGU073, 08KGU074, 08KGU075, 08KGU076, 08KGU077, 08KGU078, 08KGU079, 08KGU080, 08KGU081, 08KGU082, 08KGU083, 08KGU084, 08KGU085, 08KGU086, 08KGU087, 08KGU088, 08KGU089, 08KGU090, 08LGU001, 08LGU002, 08LGU003, 08LGU004, 08LGU005, 08LGU006, 08LGU007, 08LGU008, 08LGU009, 08LGU010, 08LGU011, 08LGU012, 08LGU013, 08LGU014, 08LGU015, 08LGU016, 08LGU017, 08LGU018, 08LGU019, 08LGU020, 09BGU081, 09BGU082, 09BGU083, 09BGU084, 09CGU001, 09CGU002, 09CGU003, 09CGU004, 09CGU005, 09CGU006, 09CGU007, 09CGU008, 09CGU009, 09CGU010, 09CGO090, 09CGU096, 09CGU097, 09CGU098, 09CGU099, 09CGU100, 09CGU101, 09CGU102, 09CGU103, 09CGU104, 09CGU105, 09CGU106, 09CGU107, 09CGU108, 09CGU109, 09CGU110, 09DGU031, 09DGU032, 09DGU033, 09DGU034, 09DGU035.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Honduras, Hong Kong, Hungary, India, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, Vietnam.
  • 제품 설명
    ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. || A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site
  • Manufacturer
    ConMed Electrosurgery

Manufacturer

ConMed Electrosurgery
  • 제조사 주소
    ConMed Electrosurgery, 14603 E Fremont Ave, Centennial CO 80112-4251
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA